Phospha 250 Neutral

Pronunciation: poe-TAS-ee-um and SOE-dee-um FOS-fates
Generic Name: Potassium and Sodium Phosphates
Brand Name: Examples include K-Phos Neutral and Phospha 250 Neutral
Phospha 250 Neutral is used for:

Increasing phosphate levels in the urine. It may also be used for other conditions as determined by your doctor.

Phospha 250 Neutral is a phosphorus supplement. It works by providing phosphate to the body.

Do NOT use Phospha 250 Neutral if: you are allergic to any ingredient in Phospha 250 Neutral you have severe kidney problems, infected kidney stones, or impacted feces you have decreased urination or are unable to urinate you have high levels of phosphate or potassium in the blood

Contact your doctor or health care provider right away if any of these apply to you.

Before using Phospha 250 Neutral:

Some medical conditions may interact with Phospha 250 Neutral. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have high blood sodium levels, low blood calcium levels, or you are on a sodium-restricted or potassium-restricted diet if you have a history of heart problems (eg, heart failure), kidney problems, kidney or other urinary stones, certain muscle problems (eg, myotonia congenita, rhabdomyolysis), stomach or bowel problems (eg, inflammation), liver problems, adrenal gland problems (eg, Addison disease), inflammation of the pancreas, or parathyroid problems if you have preeclampsia (high blood pressure during pregnancy) if you are dehydrated or have rickets, softened or weakened bones, or a urinary tract infection if you have a condition in which your skin is breaking down (eg, severe burns)

Some MEDICINES MAY INTERACT with Phospha 250 Neutral. Tell your health care provider if you are taking any other medicines, especially any of the following:

Aldosterone blockers (eg, eplerenone), aliskiren, angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), potassium-sparing diuretics (eg, triamterene), or potassium supplements because high potassium levels, possibly with irregular heartbeat or a heart attack, may occur Corticosteroids (eg, prednisone, corticotropin) or medicine for high blood pressure (eg, diazoxide, guanethidine, hydralazine, methyldopa) because the risk of high blood sodium levels may be increased Digoxin because the risk of its side effects may be increased by Phospha 250 Neutral

This may not be a complete list of all interactions that may occur. Ask your health care provider if Phospha 250 Neutral may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Phospha 250 Neutral:

Use Phospha 250 Neutral as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Phospha 250 Neutral by mouth with meals and at bedtime, unless your doctor tells you otherwise. Take Phospha 250 Neutral with a full glass of water (8 oz/240 mL). Do not take antacids containing aluminum, magnesium, or calcium with Phospha 250 Neutral without checking with your doctor or pharmacist. If you miss a dose of Phospha 250 Neutral, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Phospha 250 Neutral.

Important safety information: Phospha 250 Neutral may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Phospha 250 Neutral with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. While taking Phospha 250 Neutral, the possibility of passing old kidney stones is increased. Check with your doctor before you use a salt substitute or a product that has potassium in it. Lab tests, including kidney function and electrolyte levels (eg, calcium, potassium, phosphorus, sodium), may be performed while you use Phospha 250 Neutral. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. Phospha 250 Neutral should be used with extreme caution in CHILDREN younger than 4 years old; safety and effectiveness in these children have not been confirmed. PREGNANCY and BREAST-FEEDING: It is not known if Phospha 250 Neutral can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Phospha 250 Neutral while you are pregnant. It is not known if Phospha 250 Neutral is found in breast milk. If you are or will be breast-feeding while you use Phospha 250 Neutral, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Phospha 250 Neutral:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; nausea; stomach pain; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bone or joint pain; confusion; decreased urination; dizziness; increased thirst; irregular heartbeat; muscle cramps; numbness or tingling around the lips; numbness, tingling, pain, or weakness in the hands or feet; seizures; severe or persistent diarrhea; shortness of breath; swelling of the hands, ankles, or feet; unusual tiredness; unusual weakness or heaviness of the legs; unusual weight gain.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Phospha 250 Neutral side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Phospha 250 Neutral:

Store Phospha 250 Neutral at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Phospha 250 Neutral out of the reach of children and away from pets.

General information: If you have any questions about Phospha 250 Neutral, please talk with your doctor, pharmacist, or other health care provider. Phospha 250 Neutral is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Phospha 250 Neutral. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Phospha 250 Neutral resources Phospha 250 Neutral Side Effects (in more detail) Phospha 250 Neutral Use in Pregnancy & Breastfeeding Phospha 250 Neutral Drug Interactions Phospha 250 Neutral Support Group 0 Reviews for Phospha 250 Neutral - Add your own review/rating Phospha 250 Neutral Advanced Consumer (Micromedex) - Includes Dosage Information K-Phos M.F. Concise Consumer Information (Cerner Multum) Compare Phospha 250 Neutral with other medications Hypophosphatemia Urinary Acidification

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Potassium and Sodium Phosphates

Pronunciation: poe-TAS-ee-um and SOE-dee-um FOS-fates
Generic Name: Potassium and Sodium Phosphates
Brand Name: Examples include K-Phos Neutral and Phospha 250 Neutral
Potassium and Sodium Phosphates is used for:

Increasing phosphate levels in the urine. It may also be used for other conditions as determined by your doctor.

Potassium and Sodium Phosphates is a phosphorus supplement. It works by providing phosphate to the body.

Do NOT use Potassium and Sodium Phosphates if: you are allergic to any ingredient in Potassium and Sodium Phosphates you have severe kidney problems, infected kidney stones, or impacted feces you have decreased urination or are unable to urinate you have high levels of phosphate or potassium in the blood

Contact your doctor or health care provider right away if any of these apply to you.

Before using Potassium and Sodium Phosphates:

Some medical conditions may interact with Potassium and Sodium Phosphates. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have high blood sodium levels, low blood calcium levels, or you are on a sodium-restricted or potassium-restricted diet if you have a history of heart problems (eg, heart failure), kidney problems, kidney or other urinary stones, certain muscle problems (eg, myotonia congenita, rhabdomyolysis), stomach or bowel problems (eg, inflammation), liver problems, adrenal gland problems (eg, Addison disease), inflammation of the pancreas, or parathyroid problems if you have preeclampsia (high blood pressure during pregnancy) if you are dehydrated or have rickets, softened or weakened bones, or a urinary tract infection if you have a condition in which your skin is breaking down (eg, severe burns)

Some MEDICINES MAY INTERACT with Potassium and Sodium Phosphates. Tell your health care provider if you are taking any other medicines, especially any of the following:

Aldosterone blockers (eg, eplerenone), aliskiren, angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), potassium-sparing diuretics (eg, triamterene), or potassium supplements because high potassium levels, possibly with irregular heartbeat or a heart attack, may occur Corticosteroids (eg, prednisone, corticotropin) or medicine for high blood pressure (eg, diazoxide, guanethidine, hydralazine, methyldopa) because the risk of high blood sodium levels may be increased Digoxin because the risk of its side effects may be increased by Potassium and Sodium Phosphates

This may not be a complete list of all interactions that may occur. Ask your health care provider if Potassium and Sodium Phosphates may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Potassium and Sodium Phosphates:

Use Potassium and Sodium Phosphates as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Potassium and Sodium Phosphates by mouth with meals and at bedtime, unless your doctor tells you otherwise. Take Potassium and Sodium Phosphates with a full glass of water (8 oz/240 mL). Do not take antacids containing aluminum, magnesium, or calcium with Potassium and Sodium Phosphates without checking with your doctor or pharmacist. If you miss a dose of Potassium and Sodium Phosphates, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Potassium and Sodium Phosphates.

Important safety information: Potassium and Sodium Phosphates may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Potassium and Sodium Phosphates with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. While taking Potassium and Sodium Phosphates, the possibility of passing old kidney stones is increased. Check with your doctor before you use a salt substitute or a product that has potassium in it. Lab tests, including kidney function and electrolyte levels (eg, calcium, potassium, phosphorus, sodium), may be performed while you use Potassium and Sodium Phosphates. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. Potassium and Sodium Phosphates should be used with extreme caution in CHILDREN younger than 4 years old; safety and effectiveness in these children have not been confirmed. PREGNANCY and BREAST-FEEDING: It is not known if Potassium and Sodium Phosphates can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Potassium and Sodium Phosphates while you are pregnant. It is not known if Potassium and Sodium Phosphates is found in breast milk. If you are or will be breast-feeding while you use Potassium and Sodium Phosphates, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Potassium and Sodium Phosphates:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; nausea; stomach pain; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bone or joint pain; confusion; decreased urination; dizziness; increased thirst; irregular heartbeat; muscle cramps; numbness or tingling around the lips; numbness, tingling, pain, or weakness in the hands or feet; seizures; severe or persistent diarrhea; shortness of breath; swelling of the hands, ankles, or feet; unusual tiredness; unusual weakness or heaviness of the legs; unusual weight gain.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Potassium and Sodium Phosphates:

Store Potassium and Sodium Phosphates at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Potassium and Sodium Phosphates out of the reach of children and away from pets.

General information: If you have any questions about Potassium and Sodium Phosphates, please talk with your doctor, pharmacist, or other health care provider. Potassium and Sodium Phosphates is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Potassium and Sodium Phosphates. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Potassium and Sodium Phosphates resources Potassium and Sodium Phosphates Dosage Potassium and Sodium Phosphates Use in Pregnancy & Breastfeeding Potassium and Sodium Phosphates Drug Interactions Potassium and Sodium Phosphates Support Group 0 Reviews for Potassium and Sodium Phosphates - Add your own review/rating Compare Potassium and Sodium Phosphates with other medications Hypophosphatemia Urinary Acidification

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Ethanolamine Oleate Injection BP (UCB Pharma Ltd)

1. Name Of The Medicinal Product

Ethanolamine Oleate Injection (monoethanolamine oleate). Solution for injection.

2. Qualitative And Quantitative Composition

Oleic acid 4.23% w/v

Ethanolamine 0.910% w/v

For excipients see 6.1.

3. Pharmaceutical Form

Solution for injection.

5 ml neutral glass ampoule containing a clear solution.

4. Clinical Particulars 4.1 Therapeutic Indications

The injection is recommended for use as a sclerosing agent in the treatment of small, uncomplicated varicose veins in the lower extremities.

4.2 Posology And Method Of Administration

Ethanolamine Oleate is administered by slow intravenous injection.

Adults Including The Elderly

The product is used only as a sclerosant and injected directly into the varicose vein. A dose of 2 to 5ml, divided between 3 or 4 sites, administered by slow injection into empty isolated segments of vein.

Children

The product is not recommended for use in children.

4.3 Contraindications

Inability to walk, acute phlebitis, oral contraceptive use, obese legs, known hypersensitivity to Ethanolamine Oleate or benzyl alcohol. Superficial thrombophlebitis and deep vein thrombosis in the region of the varicose veins. Marked arterial, cardiac or renal disease. Uncontrolled metabolic disorders such as diabetes mellitus. Patients with local or systemic infections.

4.4 Special Warnings And Precautions For Use

Care should be taken to ensure that the injection does not leak into perivenous tissue which could cause sloughing, ulceration and in severe cases, necrosis.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

Safety during pregnancy has not been established. Use in pregnancy is not recommended.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Burning, cramping sensation, urticaria. Allergic reactions and anaphylaxis have been reported following use of sclerosing agents.

4.9 Overdose

Acute nephrotoxicity has been reported in two patients given 15-20ml of a solution containing 5% Ethanolamine with 2% Benzl Alcohol.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

ATC Code: C05B B 01; sclerosing agent for local injection.

Ethanolamine Oleate is an irritant. An injection of Ethanolamine Oleate into a vein irritates the intimal endothelium resulting in the formation of a thrombus. The thrombus occludes the vein and fibrous tissue develops resulting in a permanent obliteration of the vein.

5.2 Pharmacokinetic Properties

Ethanolamine Oleate is a locally acting agent. Absorption from the site of administration is not anticipated as its mode of action is to cause a permanent obstruction in the vein.

5.3 Preclinical Safety Data

None.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Benzyl alcohol

Water for Injection

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

Do not store above 25°C. Keep the ampoule in the outer carton.

6.5 Nature And Contents Of Container

5 ml Neutral Glass (Type 1) Ampoules.

6.6 Special Precautions For Disposal And Other Handling

The product is used only as a sclerosant and injected directly into the varicose vein.

7. Marketing Authorisation Holder

UCB Pharma Limited

208 Bath Road

Slough

Berkshire

SL1 3WE

UK

8. Marketing Authorisation Number(S)

PL 0039/5671R

9. Date Of First Authorisation/Renewal Of The Authorisation

27 March 1987 / 26 May 1994 / 27 May 1999

10. Date Of Revision Of The Text

June 2005

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Neutra-Phos

Generic Name: potassium phosphate and sodium phosphate (poe TASS ee um FOSS fate and SEW dee um FOSS fate)
Brand Names: K-Phos M.F., K-Phos Neutral, K-Phos No. 2, Neutra-Phos, Uro-KP-Neutral

What are Neutra-Phos (potassium phosphate and sodium phosphate)?

Phosphorus is a naturally occurring substance that is important in every cell in the body. The majority of phosphorus in the body is found in the bones. The potassium and sodium salt forms of phosphorus are called phosphates.

Potassium phosphate and sodium phosphate is used to acidify the urine and lower the urinary calcium concentration. This may reduce rash and odor caused by ammonium in the urine. Potassium phosphate and sodium phosphate may also increase the antibiotic effect of methenamine (Hiprex, Urex). Potassium phosphate and sodium phosphate is also used as a phosphorus supplement to prevent and/or treat a phosphorus deficiency.

Potassium phosphate and sodium phosphate may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Neutra-Phos (potassium phosphate and sodium phosphate)? Do not take antacids containing aluminum, calcium, or magnesium while taking potassium phosphate and sodium phosphate, except under the supervision of your doctor. Antacids may decrease phosphate absorption.

If you have kidney stones, there is a possibility that you will pass old stones after starting treatment with potassium phosphate and sodium phosphate.

Who should not take Neutra-Phos (potassium phosphate and sodium phosphate)? You cannot take potassium phosphate and sodium phosphate if you have

high levels of potassium in your body,

high levels of phosphorus in your body,

infected phosphate stones, or

severe kidney disease.

Before taking potassium phosphate and sodium phosphate, tell your doctor if you have

Addison's disease,

a bowel obstruction,

heart disease,

high blood pressure,

kidney disease, liver disease or cirrhosis,

swelling or water retention,

high levels of sodium in your body,

low levels of calcium in your body,

hypoparathyroidism,

pancreatitis, or

rickets.

You may not be able to take potassium phosphate and sodium phosphate, or you may require a lower dose or special monitoring if you have any of the conditions listed above.

Potassium phosphate and sodium phosphate is in the FDA pregnancy category C. This means that it is not known whether potassium phosphate and sodium phosphate will harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant. It is also not known whether potassium phosphate and sodium phosphate will harm a nursing infant. Do not take potassium phosphate and sodium phosphate without first talking to your doctor if you are breast-feeding baby. How should I take Neutra-Phos (potassium phosphate and sodium phosphate)?

Take potassium phosphate and sodium phosphate exactly as directed by your doctor or as directed on the package. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each tablet with a full glass of water.

The K-Phos Original tablets should be dissolved in 6 to 8 ounces (180 to 240 mL) of water. Let the tablets soak for 2 to 5 minutes, or more if necessary, and stir. If tablet particles remain, they can be crushed and stirred to speed dissolution. Drink the solution once the tablets are completely dissolved.

Do not swallow the Neutra-Phos capsules whole. They must be opened, and the contents mixed with water. Mix the Neutra-Phos powder and capsule contents with 75 mL (approximately one-third cup) of water, and drink the solution. Do not take more of this medication than is recommended. If your symptoms are not being treated, notify your doctor. Store potassium phosphate and sodium phosphate at room temperature away from moisture and heat. What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication unless otherwise directed.

What happens if I overdose? Seek emergency medical attention.

Most commonly, symptoms of an overdose include nausea, vomiting, diarrhea, dehydration, and severe and prolonged muscle cramps or paralysis.

What should I avoid while taking Neutra-Phos (potassium phosphate and sodium phosphate)? Do not take antacids containing aluminum, calcium, or magnesium while taking potassium phosphate and sodium phosphate, except under the supervision of your doctor. Antacids may decrease phosphate absorption. Neutra-Phos (potassium phosphate and sodium phosphate) side effects Stop taking potassium phosphate and sodium phosphate and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).

Other, less serious side effects may also to occur. Nausea, vomiting, stomach pain, and diarrhea are among the most common. These side effects usually lessen after a few days of therapy. Notify your doctor if you develop these side effects.

If you have kidney stones, there is a possibility that you will pass old stones after starting treatment with potassium phosphate and sodium phosphate.

Less commonly, the following side effects have been reported:

headache;

dizziness or confusion;

weakness or heaviness of the legs;

diarrhea;

seizures;

unusual tiredness or weakness;

muscle cramps;

numbness, tingling, pain, or weakness of the hands or feet;

swelling of the feet or lower legs;

unusual weight gain;

increased thirst;

decreased urine; or

bone or joint pain.

Notify your doctor if you develop any of the side effects listed above.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Neutra-Phos (potassium phosphate and sodium phosphate)? Do not take antacids containing aluminum, calcium, or magnesium while taking potassium phosphate and sodium phosphate, except under the supervision of your doctor. Antacids may decrease phosphate absorption.

Before taking potassium phosphate and sodium phosphate, tell your doctor if you are taking any of the following medicines

calcium and/or vitamin D supplements;

potassium supplements or salt substitutes;

a diuretic (water pill) such as triamterene (Dyrenium, Dyazide, Maxzide), spironolactone (Aldactone), or amiloride (Midamor);

a heart medication such as guanethidine (Ismelin), diazoxide (Hyperstat, Proglycem), hydralazine (Apresoline), methyldopa (Aldomet), or reserpine (Ser-Ap-Es); or

a steroid medicine such as corticotropin (ACTH, Acthar), cortisone (Cortone), hydrocortisone (Cortef, others), prednisone (Orasone, Deltasone, others), prednisolone (Prelone, Pediapred, Delta-Cortef, others), methylprednisolone (Medrol, others), triamcinolone (Aristocort, Kenalog, Tri-Kort, Trilog, others), dexamethasone (Decadron), or betamethasone (Celestone).

You may require a dosage adjustment or special monitoring if you are taking any of the medicines listed above.

Drugs other than those listed here may also interact with potassium phosphate and sodium phosphate. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

More Neutra-Phos resources Neutra-Phos Side Effects (in more detail) Neutra-Phos Use in Pregnancy & Breastfeeding Neutra-Phos Drug Interactions Neutra-Phos Support Group 0 Reviews for Neutra-Phos - Add your own review/rating K-Phos Neutral Advanced Consumer (Micromedex) - Includes Dosage Information K-Phos Neutral MedFacts Consumer Leaflet (Wolters Kluwer) Compare Neutra-Phos with other medications Hypophosphatemia Urinary Acidification Where can I get more information? Your pharmacist has more information about potassium phosphate and sodium phosphate written for health professionals that you may read.

See also: Neutra-Phos side effects (in more detail)

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phosphate supplement Oral, Parenteral

Commonly used brand name(s)

In the U.S.

Fleet Phospho-soda EZ-Prep K-Phos Neutral K-Phos Original OsmoPrep Phospha 250 Neutral Phospho-Soda Visicol

Available Dosage Forms:

Tablet Tablet, Enteric Coated Liquid Uses For phosphate supplement

Phosphates are used as dietary supplements for patients who are unable to get enough phosphorus in their regular diet, usually because of certain illnesses or diseases. Phosphate is the drug form (salt) of phosphorus. Some phosphates are used to make the urine more acid, which helps treat certain urinary tract infections. Some phosphates are used to prevent the formation of calcium stones in the urinary tract.

Injectable phosphates are to be administered only by or under the supervision of your health care professional. Some of these oral preparations are available only with a prescription. Others are available without a prescription; however, your health care professional may have special instructions on the proper dose of phosphate supplement for your medical condition. You should take phosphates only under the supervision of your health care professional.

Importance of Diet

For good health, it is important that you eat a balanced and varied diet. Follow carefully any diet program your health care professional may recommend. For your specific dietary vitamin and/or mineral needs, ask your health care professional for a list of appropriate foods. If you think that you are not getting enough vitamins and/or minerals in your diet, you may choose to take a dietary supplement.

The best dietary sources of phosphorus include dairy products, meat, poultry, fish, and cereal products.

The daily amount of phosphorus needed is defined in several different ways.

For U.S.— Recommended Dietary Allowances (RDAs) are the amount of vitamins and minerals needed to provide for adequate nutrition in most healthy persons. RDAs for a given nutrient may vary depending on a person's age, sex, and physical condition (e.g., pregnancy). Daily Values (DVs) are used on food and dietary supplement labels to indicate the percent of the recommended daily amount of each nutrient that a serving provides. DV replaces the previous designation of United States Recommended Daily Allowances (USRDAs). For Canada— Recommended Nutrient Intakes (RNIs) are used to determine the amounts of vitamins, minerals, and protein needed to provide adequate nutrition and lessen the risk of chronic disease.

Normal daily recommended intakes for phosphorus are generally defined as follows:

Persons U.S.
(mg) Canada
(mg) Infants birth to 3 years of age 300–800 150–350 Children 4 to 6 years of age 800 400 Children 7 to 10 years of age 800 500–800 Adolescent and adult males 800–1200 700–1000 Adolescent and adult females 800–1200 800–850 Pregnant females 1200 1050 Breast-feeding females 1200 1050 Before Using phosphate supplement

If you are taking a dietary supplement without a prescription, carefully read and follow any precautions on the label. For these supplements, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Problems in children have not been reported with intake of normal daily recommended amounts. However, use of enemas that contain phosphates in children has resulted in high blood levels of phosphorus.

Geriatric

Problems in older adults have not been reported with intake of normal daily recommended amounts.

Pregnancy

It is especially important that you are receiving enough vitamins and minerals when you become pregnant and that you continue to receive the right amount of vitamins and minerals throughout your pregnancy. The healthy growth and development of the fetus depend on a steady supply of nutrients from the mother. However, taking large amounts of a dietary supplement in pregnancy may be harmful to the mother and/or fetus and should be avoided.

Breast Feeding

It is especially important that you receive the right amount of vitamins and minerals so that your baby will also get the vitamins and minerals needed to grow properly. However, taking large amounts of a dietary supplement while breast-feeding may be harmful to the mother and/or baby and should be avoided.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking any of these dietary supplements, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using dietary supplements in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with dietary supplements in this class or change some of the other medicines you take.

Amantadine Atropine Belladonna Belladonna Alkaloids Benztropine Biperiden Cisapride Clidinium Darifenacin Dicyclomine Dronedarone Eplerenone Glycopyrrolate Hyoscyamine Mesoridazine Methscopolamine Oxybutynin Pimozide Procyclidine Scopolamine Solifenacin Sparfloxacin Thioridazine Tolterodine Trihexyphenidyl

Using dietary supplements in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Alacepril Alfuzosin Amiloride Amiodarone Amitriptyline Amoxapine Apomorphine Arsenic Trioxide Asenapine Astemizole Azithromycin Benazepril Canrenoate Captopril Chloroquine Chlorpromazine Cilazapril Ciprofloxacin Citalopram Clarithromycin Clomipramine Clozapine Crizotinib Dasatinib Delapril Desipramine Disopyramide Dofetilide Dolasetron Droperidol Enalaprilat Enalapril Maleate Erythromycin Flecainide Fluconazole Fosinopril Gatifloxacin Gemifloxacin Granisetron Halofantrine Haloperidol Ibutilide Iloperidone Imidapril Imipramine Indomethacin Lapatinib Levofloxacin Lisinopril Lopinavir Lumefantrine Mefloquine Methadone Moexipril Moxifloxacin Nilotinib Norfloxacin Nortriptyline Octreotide Ofloxacin Ondansetron Paliperidone Pazopanib Pentopril Perflutren Lipid Microsphere Perindopril Posaconazole Procainamide Prochlorperazine Promethazine Propafenone Protriptyline Quetiapine Quinapril Quinidine Quinine Ramipril Ranolazine Salmeterol Saquinavir Solifenacin Sorafenib Sotalol Spirapril Spironolactone Sunitinib Telavancin Telithromycin Temocapril Terfenadine Tetrabenazine Toremifene Trandolapril Trazodone Triamterene Trifluoperazine Trimipramine Vandetanib Vardenafil Vemurafenib Voriconazole Ziprasidone Zofenopril Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of dietary supplements in this class. Make sure you tell your doctor if you have any other medical problems, especially:

Burns, severe or Heart disease or Pancreatitis (inflammation of the pancreas) or Rickets or Softening of bones or Underactive parathyroid glands—Sodium- or potassium-containing phosphates may make these conditions worse. Dehydration or Underactive adrenal glands—Potassium-containing phosphates may increase the risk of hyperkalemia (too much potassium in the blood). Edema (swelling in feet or lower legs or fluid in lungs) or High blood pressure or Liver disease or Toxemia of pregnancy—Sodium-containing phosphates may make these conditions worse. High blood levels of phosphate (hyperphosphatemia)—Use of phosphates may make this condition worse. Infected kidney stones—Phosphates may make this condition worse. Kidney disease—Sodium-containing phosphates may make this condition worse; potassium-containing phosphates may increase the risk of hyperkalemia (too much potassium in the blood). Myotonia congenita—Potassium-containing phosphates may increase the risk of hyperkalemia (too much potassium in the blood), and make this condition worse. Proper Use of phosphate supplement

For patients taking the tablet form of phosphate supplement:

Do not swallow the tablet. Before taking, dissolve the tablet in ? to 1 glass (6 to 8 ounces) of water. Let the tablet soak in water for 2 to 5 minutes and then stir until completely dissolved.

For patients using the capsule form of phosphate supplement:

Do not swallow the capsule. Before taking, mix the contents of 1 capsule in one-third glass (about 2? ounces) of water or juice or the contents of 2 capsules in two-thirds glass (about 5 ounces) of water and stir well until dissolved.

For patients using the powder form of phosphate supplement:

Add the entire contents of 1 bottle (2? ounces) to enough warm water to make 1 gallon of solution or the contents of one packet to enough warm water to make 1/3 of a glass (about 2.5 ounces) of solution. Shake the container for 2 or 3 minutes or until all the powder is dissolved. Do not dilute solution further. This solution may be chilled to improve the flavor; do not allow it to freeze. Discard unused solution after 60 days.

Take phosphate supplement immediately after meals or with food to lessen possible stomach upset or laxative action.

To help prevent kidney stones, drink at least a full glass (8 ounces) of water every hour during waking hours, unless otherwise directed by your health care professional.

Take phosphate supplement only as directed. Do not take more of it and do not take it more often than recommended on the label, unless otherwise directed by your health care professional.

Dosing

The dose medicines in this class will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For potassium phosphates For oral dosage form (solution): To replace phosphorus lost by the body or to make the urine more acid or to prevent the formation of kidney stones in the urinary tract: Adults and teenagers—The equivalent of 228 milligrams (mg) of phosphorus (2 tablets) dissolved in six to eight ounces of water four times a day, with meals and at bedtime. To replace phosphorus lost by the body: Children over 4 years of age—The equivalent of 228 mg of phosphorus (2 tablets) dissolved in six to eight ounces of water four times a day, with meals and at bedtime. Children up to 4 years of age—The dose must be determined by your doctor. For oral dosage forms (capsules or oral solution): To replace phosphorus lost by the body: Adults, teenagers, and children over 4 years of age—The equivalent of 250 mg of phosphorus (contents of 1 capsule) dissolved in two and one-half ounces of water or juice four times a day, after meals and at bedtime. Children up to 4 years of age—Dose must be determined by your doctor. For oral dosage forms (powder for oral solution): To replace phosphorus lost by the body: Adults, teenagers, and children over 4 years of age—The equivalent of 250 mg of phosphorus dissolved in two and one-half ounces of water four times a day, after meals and at bedtime. Children up to 4 years of age—Dose must be determined by your doctor. For potassium and sodium phosphates For oral dosage form (solution): To replace phosphorus lost by the body or to make the urine more acid or to prevent the formation of kidney stones in the urinary tract: Adults and teenagers—The equivalent of 250 milligrams (mg) of phosphorus dissolved in eight ounces of water four times a day, after meals and at bedtime. To replace phosphorus lost by the body: Children over 4 years of age—The equivalent of 250 mg of phosphorus dissolved in eight ounces of water four times a day, after meals and at bedtime. Children up to 4 years of age—Dose must be determined by your doctor. For oral dosage forms (capsules or solution): To replace phosphorus lost by the body: Adults, teenagers, and children over 4 years of age—The equivalent of 250 mg of phosphorus (the contents of 1 capsule) dissolved in two and one-half ounces of water or juice four times a day, after meals and at bedtime. Children up to 4 years of age—Dose must be determined by your doctor. For oral dosage forms (powder for solution): To replace phosphorus lost by the body: Adults, teenagers, and children over 4 years of age—The equivalent of 250 mg of phosphorus dissolved in two and one-half ounces of water four times a day, after meals and at bedtime. Children up to 4 years of age—Dose must be determined by your doctor. For oral dosage forms (tablets for solution): To replace phosphorus lost by the body: Adults, teenagers, and children over 4 years of age—The equivalent of 250 mg of phosphorus (1 tablet) dissolved in eight ounces of water four times a day. Children up to 4 years of age—Dose must be determined by your doctor. Missed Dose

If you miss a dose of phosphate supplement, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using phosphate supplement

Your health care professional should check your progress at regular visits to make sure that phosphate supplement does not cause unwanted effects.

Do not take iron supplements within 1 to 2 hours of taking phosphate supplement. To do so may keep the iron from working properly.

For patients taking potassium phosphate-containing medicines:

Check with your health care professional before starting any strenuous physical exercise, especially if you are out of condition and are taking other medication. Exercise and certain medicines may increase the amount of potassium in the blood.

For patients on a potassium-restricted diet:

phosphate supplement may contain a large amount of potassium. If you have any questions about this, check with your health care professional. Do not use salt substitutes and low-salt milk unless told to do so by your health care professional. They may contain potassium.

For patients on a sodium-restricted diet:

phosphate supplement may contain a large amount of sodium. If you have any questions about this, check with your health care professional. phosphate supplement Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Less common or rare Confusion convulsions (seizures) decrease in amount of urine or in frequency of urination fast, slow, or irregular heartbeat headache or dizziness increased thirst muscle cramps numbness, tingling, pain, or weakness in hands or feet numbness or tingling around lips shortness of breath or troubled breathing swelling of feet or lower legs tremor unexplained anxiety unusual tiredness or weakness weakness or heaviness of legs weight gain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Diarrhea nausea or vomiting stomach pain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

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Fleet Phospho-soda EZ-Prep

Generic Name: phosphate supplement (Oral route, Parenteral route)

Commonly used brand name(s)

In the U.S.

Fleet Phospho-soda EZ-Prep K-Phos Neutral K-Phos Original OsmoPrep Phospha 250 Neutral Phospho-Soda Visicol

Available Dosage Forms:

Tablet Tablet, Enteric Coated Liquid Uses For Fleet Phospho-soda EZ-Prep

Phosphates are used as dietary supplements for patients who are unable to get enough phosphorus in their regular diet, usually because of certain illnesses or diseases. Phosphate is the drug form (salt) of phosphorus. Some phosphates are used to make the urine more acid, which helps treat certain urinary tract infections. Some phosphates are used to prevent the formation of calcium stones in the urinary tract.

Injectable phosphates are to be administered only by or under the supervision of your health care professional. Some of these oral preparations are available only with a prescription. Others are available without a prescription; however, your health care professional may have special instructions on the proper dose of this medicine for your medical condition. You should take phosphates only under the supervision of your health care professional.

Importance of Diet

For good health, it is important that you eat a balanced and varied diet. Follow carefully any diet program your health care professional may recommend. For your specific dietary vitamin and/or mineral needs, ask your health care professional for a list of appropriate foods. If you think that you are not getting enough vitamins and/or minerals in your diet, you may choose to take a dietary supplement.

The best dietary sources of phosphorus include dairy products, meat, poultry, fish, and cereal products.

The daily amount of phosphorus needed is defined in several different ways.

For U.S.— Recommended Dietary Allowances (RDAs) are the amount of vitamins and minerals needed to provide for adequate nutrition in most healthy persons. RDAs for a given nutrient may vary depending on a person's age, sex, and physical condition (e.g., pregnancy). Daily Values (DVs) are used on food and dietary supplement labels to indicate the percent of the recommended daily amount of each nutrient that a serving provides. DV replaces the previous designation of United States Recommended Daily Allowances (USRDAs). For Canada— Recommended Nutrient Intakes (RNIs) are used to determine the amounts of vitamins, minerals, and protein needed to provide adequate nutrition and lessen the risk of chronic disease.

Normal daily recommended intakes for phosphorus are generally defined as follows:

Persons U.S.
(mg) Canada
(mg) Infants birth to 3 years of age 300–800 150–350 Children 4 to 6 years of age 800 400 Children 7 to 10 years of age 800 500–800 Adolescent and adult males 800–1200 700–1000 Adolescent and adult females 800–1200 800–850 Pregnant females 1200 1050 Breast-feeding females 1200 1050 Before Using Fleet Phospho-soda EZ-Prep

If you are taking a dietary supplement without a prescription, carefully read and follow any precautions on the label. For these supplements, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Problems in children have not been reported with intake of normal daily recommended amounts. However, use of enemas that contain phosphates in children has resulted in high blood levels of phosphorus.

Geriatric

Problems in older adults have not been reported with intake of normal daily recommended amounts.

Pregnancy

It is especially important that you are receiving enough vitamins and minerals when you become pregnant and that you continue to receive the right amount of vitamins and minerals throughout your pregnancy. The healthy growth and development of the fetus depend on a steady supply of nutrients from the mother. However, taking large amounts of a dietary supplement in pregnancy may be harmful to the mother and/or fetus and should be avoided.

Breast Feeding

It is especially important that you receive the right amount of vitamins and minerals so that your baby will also get the vitamins and minerals needed to grow properly. However, taking large amounts of a dietary supplement while breast-feeding may be harmful to the mother and/or baby and should be avoided.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking any of these dietary supplements, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using dietary supplements in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with dietary supplements in this class or change some of the other medicines you take.

Amantadine Atropine Belladonna Belladonna Alkaloids Benztropine Biperiden Cisapride Clidinium Darifenacin Dicyclomine Dronedarone Eplerenone Glycopyrrolate Hyoscyamine Mesoridazine Methscopolamine Oxybutynin Pimozide Procyclidine Scopolamine Solifenacin Sparfloxacin Thioridazine Tolterodine Trihexyphenidyl

Using dietary supplements in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Alacepril Alfuzosin Amiloride Amiodarone Amitriptyline Amoxapine Apomorphine Arsenic Trioxide Asenapine Astemizole Azithromycin Benazepril Canrenoate Captopril Chloroquine Chlorpromazine Cilazapril Ciprofloxacin Citalopram Clarithromycin Clomipramine Clozapine Crizotinib Dasatinib Delapril Desipramine Disopyramide Dofetilide Dolasetron Droperidol Enalaprilat Enalapril Maleate Erythromycin Flecainide Fluconazole Fosinopril Gatifloxacin Gemifloxacin Granisetron Halofantrine Haloperidol Ibutilide Iloperidone Imidapril Imipramine Indomethacin Lapatinib Levofloxacin Lisinopril Lopinavir Lumefantrine Mefloquine Methadone Moexipril Moxifloxacin Nilotinib Norfloxacin Nortriptyline Octreotide Ofloxacin Ondansetron Paliperidone Pazopanib Pentopril Perflutren Lipid Microsphere Perindopril Posaconazole Procainamide Prochlorperazine Promethazine Propafenone Protriptyline Quetiapine Quinapril Quinidine Quinine Ramipril Ranolazine Salmeterol Saquinavir Solifenacin Sorafenib Sotalol Spirapril Spironolactone Sunitinib Telavancin Telithromycin Temocapril Terfenadine Tetrabenazine Toremifene Trandolapril Trazodone Triamterene Trifluoperazine Trimipramine Vandetanib Vardenafil Vemurafenib Voriconazole Ziprasidone Zofenopril Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of dietary supplements in this class. Make sure you tell your doctor if you have any other medical problems, especially:

Burns, severe or Heart disease or Pancreatitis (inflammation of the pancreas) or Rickets or Softening of bones or Underactive parathyroid glands—Sodium- or potassium-containing phosphates may make these conditions worse. Dehydration or Underactive adrenal glands—Potassium-containing phosphates may increase the risk of hyperkalemia (too much potassium in the blood). Edema (swelling in feet or lower legs or fluid in lungs) or High blood pressure or Liver disease or Toxemia of pregnancy—Sodium-containing phosphates may make these conditions worse. High blood levels of phosphate (hyperphosphatemia)—Use of phosphates may make this condition worse. Infected kidney stones—Phosphates may make this condition worse. Kidney disease—Sodium-containing phosphates may make this condition worse; potassium-containing phosphates may increase the risk of hyperkalemia (too much potassium in the blood). Myotonia congenita—Potassium-containing phosphates may increase the risk of hyperkalemia (too much potassium in the blood), and make this condition worse. Proper Use of phosphate supplement

This section provides information on the proper use of a number of products that contain phosphate supplement. It may not be specific to Fleet Phospho-soda EZ-Prep. Please read with care.

For patients taking the tablet form of this medicine:

Do not swallow the tablet. Before taking, dissolve the tablet in ? to 1 glass (6 to 8 ounces) of water. Let the tablet soak in water for 2 to 5 minutes and then stir until completely dissolved.

For patients using the capsule form of this medicine:

Do not swallow the capsule. Before taking, mix the contents of 1 capsule in one-third glass (about 2? ounces) of water or juice or the contents of 2 capsules in two-thirds glass (about 5 ounces) of water and stir well until dissolved.

For patients using the powder form of this medicine:

Add the entire contents of 1 bottle (2? ounces) to enough warm water to make 1 gallon of solution or the contents of one packet to enough warm water to make 1/3 of a glass (about 2.5 ounces) of solution. Shake the container for 2 or 3 minutes or until all the powder is dissolved. Do not dilute solution further. This solution may be chilled to improve the flavor; do not allow it to freeze. Discard unused solution after 60 days.

Take this medicine immediately after meals or with food to lessen possible stomach upset or laxative action.

To help prevent kidney stones, drink at least a full glass (8 ounces) of water every hour during waking hours, unless otherwise directed by your health care professional.

Take this medicine only as directed. Do not take more of it and do not take it more often than recommended on the label, unless otherwise directed by your health care professional.

Dosing

The dose medicines in this class will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For potassium phosphates For oral dosage form (solution): To replace phosphorus lost by the body or to make the urine more acid or to prevent the formation of kidney stones in the urinary tract: Adults and teenagers—The equivalent of 228 milligrams (mg) of phosphorus (2 tablets) dissolved in six to eight ounces of water four times a day, with meals and at bedtime. To replace phosphorus lost by the body: Children over 4 years of age—The equivalent of 228 mg of phosphorus (2 tablets) dissolved in six to eight ounces of water four times a day, with meals and at bedtime. Children up to 4 years of age—The dose must be determined by your doctor. For oral dosage forms (capsules or oral solution): To replace phosphorus lost by the body: Adults, teenagers, and children over 4 years of age—The equivalent of 250 mg of phosphorus (contents of 1 capsule) dissolved in two and one-half ounces of water or juice four times a day, after meals and at bedtime. Children up to 4 years of age—Dose must be determined by your doctor. For oral dosage forms (powder for oral solution): To replace phosphorus lost by the body: Adults, teenagers, and children over 4 years of age—The equivalent of 250 mg of phosphorus dissolved in two and one-half ounces of water four times a day, after meals and at bedtime. Children up to 4 years of age—Dose must be determined by your doctor. For potassium and sodium phosphates For oral dosage form (solution): To replace phosphorus lost by the body or to make the urine more acid or to prevent the formation of kidney stones in the urinary tract: Adults and teenagers—The equivalent of 250 milligrams (mg) of phosphorus dissolved in eight ounces of water four times a day, after meals and at bedtime. To replace phosphorus lost by the body: Children over 4 years of age—The equivalent of 250 mg of phosphorus dissolved in eight ounces of water four times a day, after meals and at bedtime. Children up to 4 years of age—Dose must be determined by your doctor. For oral dosage forms (capsules or solution): To replace phosphorus lost by the body: Adults, teenagers, and children over 4 years of age—The equivalent of 250 mg of phosphorus (the contents of 1 capsule) dissolved in two and one-half ounces of water or juice four times a day, after meals and at bedtime. Children up to 4 years of age—Dose must be determined by your doctor. For oral dosage forms (powder for solution): To replace phosphorus lost by the body: Adults, teenagers, and children over 4 years of age—The equivalent of 250 mg of phosphorus dissolved in two and one-half ounces of water four times a day, after meals and at bedtime. Children up to 4 years of age—Dose must be determined by your doctor. For oral dosage forms (tablets for solution): To replace phosphorus lost by the body: Adults, teenagers, and children over 4 years of age—The equivalent of 250 mg of phosphorus (1 tablet) dissolved in eight ounces of water four times a day. Children up to 4 years of age—Dose must be determined by your doctor. Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Fleet Phospho-soda EZ-Prep

Your health care professional should check your progress at regular visits to make sure that this medicine does not cause unwanted effects.

Do not take iron supplements within 1 to 2 hours of taking this medicine. To do so may keep the iron from working properly.

For patients taking potassium phosphate-containing medicines:

Check with your health care professional before starting any strenuous physical exercise, especially if you are out of condition and are taking other medication. Exercise and certain medicines may increase the amount of potassium in the blood.

For patients on a potassium-restricted diet:

This medicine may contain a large amount of potassium. If you have any questions about this, check with your health care professional. Do not use salt substitutes and low-salt milk unless told to do so by your health care professional. They may contain potassium.

For patients on a sodium-restricted diet:

This medicine may contain a large amount of sodium. If you have any questions about this, check with your health care professional. Fleet Phospho-soda EZ-Prep Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Less common or rare Confusion convulsions (seizures) decrease in amount of urine or in frequency of urination fast, slow, or irregular heartbeat headache or dizziness increased thirst muscle cramps numbness, tingling, pain, or weakness in hands or feet numbness or tingling around lips shortness of breath or troubled breathing swelling of feet or lower legs tremor unexplained anxiety unusual tiredness or weakness weakness or heaviness of legs weight gain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Diarrhea nausea or vomiting stomach pain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

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Fibro-Vein 3.0%, 1.0%, 0.5%, 0.2%

1. Name Of The Medicinal Product

Fibro-vein 3.0%, 1.0%, 0.5%, 0.2%

2. Qualitative And Quantitative Composition

Active ingredient

Fibro-vein 3% Sodium Tetradecyl Sulphate BP 3.0% w/v

Fibro-vein 1% Sodium Tetradecyl Sulphate BP 1.0% w/v

Fibro-vein 0.5% Sodium Tetradecyl Sulphate BP 0.5% w/v

Fibro-vein 0.2% Sodium Tetradecyl Sulphate BP 0.2% w/v

For excipients, see 6.1

3. Pharmaceutical Form

Intravenous injection

4. Clinical Particulars 4.1 Therapeutic Indications

Fibro-vein 3%

For the treatment of varicose veins of the leg by injection sclerotherapy.

Fibro-vein 1%

For the treatment of small varicose veins and the larger venules of the leg by injection sclerotherapy.

Fibro-vein 0.5%

For the treatment of minor venules and spider veins (venous flares) of the leg by injection sclerotherapy.

Fibro-vein 0.2%

For the treatment of minor venules and spider veins (venous flares) by injection sclerotherapy.

4.2 Posology And Method Of Administration

Route of administration

For intravenous administration into the lumen of an isolated segment of emptied vein followed by immediate continuous compression.

Recommended doses and dosage schedules.

Adults

Fibro-vein 3%

0.5 to 1.0ml of 3.0% Fibro-vein injected intravenously at each of 4 sites (maximum 4ml).

Fibro-vein 1%

0.25 to 1.0ml of 1.0% Fibro-vein injected intravenously at each of 10 sites (maximum 10ml).

Fibro-vein 0.5%

0.25 to 1.0ml of 0.5% Fibro-vein injected intravenously at each of 10 sites (maximum 10ml).

Fibro-vein 0.2%

0.1 to 1.0ml of Fibro-vein 0.2% injected intravenously at each of 10 sites (maximum 10ml).

The smallest of needles (30 gauge) should be used to perform the injection which should be made slowly so that the blood content of these veins is expelled. In the treatment of spider veins an air block technique may be used.

Children

Not recommended in children

The elderly

As for adults

4.3 Contraindications

1. Allergy to sodium tetradecyl sulphate or to any component of the preparation.

2. Patients unable to walk due to any cause.

3. Patients currently taking oral contraceptives.

4. Significant obesity.

5. Acute superficial thrombophlebitis.

6. Local or systemic infection.

7. Varicosities caused by pelvic or abdominal tumours.

8. Uncontrolled systemic disease eg diabetes mellitus.

9. Surgical valvular incompetence requiring surgical treatment.

4.4 Special Warnings And Precautions For Use

1. Fibro-vein should only be administered by practitioners familiar with an acceptable injection technique. Thorough pre-injection assessment for valvular competence and deep vein patency must be carried out.

Extreme care in needle placement and slow injection of the minimal effective volume at each injection site are essential for safe and efficient use.

2. A history of allergy should be taken from all patients prior to treatment. Where special caution is indicated a test dose of 0.25 to 0.5ml Fibro-vein should be given up to 24 hours before any further therapy.

3. Treatment of anaphylaxis may require, depending on the severity of attack, some or all of the following: injection of adrenaline, injection of hydrocortisone, injection of antihistamine, endotracheal intubation with use of a laryngoscope and suction.

The treatment of varicose veins by Fibro-vein should not be undertaken in clinics where these items are not readily available.

4. Extreme caution in use is required in patients with arterial disease such as severe peripheral atherosclerosis or thromboangiitis obliterans (Buerger's disease).

5. Special care is required when injecting above and posterior to the medial malleolus where the posterior tibial artery may be at risk.

6. Pigmentation may be more likely to result if blood is extravasated at the injection site (particularly when treating smaller surface veins) and compression is not used.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Do not use with heparin in the same syringe

4.6 Pregnancy And Lactation

Safety for use in pregnancy has not been established. Use only when clearly needed for symptomatic relief and when the potential benefits outweigh the potential hazards to the foetus.

It is not known whether sodium tetradecyl sulphate is excreted in human milk. Caution should be exercised when used in nursing mothers.

4.7 Effects On Ability To Drive And Use Machines

None known

4.8 Undesirable Effects

1. Local: Pain or burning. Skin pigmentation. Tissue necrosis and ulceration may occur with extravasation. Paraesthesia and anaesthesia may occur if an injection effects a cutaneous nerve.

2. Vascular: Superficial thrombophlebitis. Deep vein thrombosis and pulmonary embolism are very rare. Inadvertent intra-arterial injection is very rare but may lead to gangrene. Most cases have involved the posterior tibial artery above the medial malleolus.

3. Systemic reactions: Allergic reactions are rare, presenting as local or generalised rash, urticaria, nausea or vomiting, asthma, vascular collapse. Anaphylactic shock, which may potentially be fatal, is extremely rare.

4.9 Overdose

Not applicable.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Sodium tetradecyl sulphate damages the endothelium cells within the lumen of the injected vein. The object of compression sclerotherapy is then to compress the vein so that the resulting thrombus is kept to the minimum and the subsequent formation of scar tissue within the vein produces a fibrous cord and permanent obliteration. Non-compressed veins permit the formation of a large thrombus and produce less fibrosis within the vein.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

Not applicable

6. Pharmaceutical Particulars 6.1 List Of Excipients

Benzyl Alcohol BP 2.0% w/v

Di-Sodium Hydrogen Phosphate BP 0.75% w/v

Potassium Di-Hydrogen Phosphate BP 0.1% w/v

Water For Injection BP to 100%

Potassium Di-Hydrogen Phosphate* BP qs

Sodium Carbonate (anhydrous)* BP qs

Sodium Hydroxide (5% soln)* BP qs

* Either sodium carbonate or sodium hydroxide is used for adjustment of pH

6.2 Incompatibilities

Do not use with heparin in the same syringe

6.3 Shelf Life

36 months

6.4 Special Precautions For Storage

Store below 25°C away from direct sunlight

6.5 Nature And Contents Of Container

2ml ampoules type 1 neutral hydrolytic glass conforming with EP requirements for injectable preparations. Five 2ml ampoules per pack.

5ml glass vials type 1 neutral hydrolytic glass conforming with EP requirements for injectable preparations. Sealed with a chlorobutyl rubber bung and silver aluminium "tear off" seal conforming with the European Pharmacopoeia requirements. Ten 5ml vials per pack.

Fibro-vein 3.0% available as 5 x 2ml ampoules and 10 x 5ml vials

Fibro-vein 1.0% available as 5 x 2ml ampoules

Fibro-vein 0.5% available as 5 x 2ml ampoules

Fibro-vein 0.2% available as 5 x 2ml ampoules and 10 x 5ml vials

6.6 Special Precautions For Disposal And Other Handling

The in use period of each 5ml multidose vial is a single session of therapy and for use in the treatment of a single patient. Unused vial contents should be discarded immediately afterwards.

7. Marketing Authorisation Holder

STD Pharmaceutical Products Ltd

Plough Lane

Hereford

HR4 0EL

United Kingdom

8. Marketing Authorisation Number(S)

Fibro-vein 3.0% PL 0398/5000R

Fibro-vein 1.0% PL 0398/0003

Fibro-vein 0.5% PL 0398/0002

Fibro-vein 0.2% PL 0398/0004

9. Date Of First Authorisation/Renewal Of The Authorisation

Fibro-vein 3.0% 23/02/2006

Fibro-vein 1.0% 26/03/2008

Fibro-vein 0.5% 26/03/2008

Fibro-vein 0.2% 26/03/2008

10. Date Of Revision Of The Text

26/03/2008

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Hypurin Porcine Isophane Vials

1. Name Of The Medicinal Product

Hypurin® Porcine Isophane

2. Qualitative And Quantitative Composition

Crystalline Insulin Ph Eur (Porcine) 100 IU/ml.

Isophane Insulin Injection Ph Eur (Porcine)

For excipients, see 6.1

3. Pharmaceutical Form

Suspension for injection.

A white suspension

4. Clinical Particulars 4.1 Therapeutic Indications

The treatment of insulin dependent diabetes mellitus.

May be used for diabetics requiring a depot insulin of medium duration. Where a more rapid, intense onset is desirable it may be mixed with Hypurin Neutral.

4.2 Posology And Method Of Administration

Usually administered subcutaneously but where necessary it may be given intramuscularly in which case onset is more rapid and overall duration shorter. It should not be given intravenously. Onset of action occurs within 2 hours after subcutaneous injection with an overall duration of 18-24 hours. Maximum effect is exerted between 6-12 hours.

4.3 Contraindications

Hypoglycaemia.

Hypersensitivity to insulin or to any of the excipients.

4.4 Special Warnings And Precautions For Use

In no circumstances must Hypurin® Porcine Isophane be given intravenously.

Hypoglycaemia: Susceptibility to hypoglycaemia may be increased by an inaccurate or excessive dosage of insulin, the omission of a meal by the patient or increased physical activity. Correct insulin administration and awareness of the symptoms of hypoglycaemia are essential to reduce the risk of hypoglycaemia (see section 4.9).

Blood or urinary glucose concentrations should be monitored and the urine tested for ketones by patients on insulin therapy.

Newly diagnosed diabetic patients may experience fluctuating insulin requirements during the first weeks, months or even years of treatment (the so-called 'honeymoon period').

Patients transferred to Hypurin® Porcine insulins from other commercially available preparations may require dosage adjustments.

The warning symptoms of hypoglycaemia may be changed, be less pronounced or absent in certain risk groups who should be advised accordingly. These include patients:

- in whom glycaemic control is greatly improved, e.g. by intensified insulin therapy

- with a long history of diabetes

- who are elderly

- receiving concomitant treatment with certain medicinal products e.g. beta blockers or clonidine.

Elderly diabetic patients are more susceptible to episodes of severe, rapid onset hypoglycaemia.

Combination of Hypurin® insulins with pioglitazone: Cases of cardiac failure have been reported when thiazolidinediones are used in combination with insulin, especially in patients with risk factors for development of cardiac heart failure. This should be kept in mind if treatment with the combination of pioglitazone and Hypurin® is considered. If the combination is used, patients should be observed for signs and symptoms of heart failure, weight gain and oedema. Pioglitazone should be discontinued if any deterioration in cardiac symptoms occurs.

Insulin requirements may increase during illness (this includes infection and accidental and surgical trauma), puberty or emotional upset.

Insulin resistance is frequently associated with lipid disorders, hypertension and ischaemic heart disease. Patients with insulin resistance usually require more than 200 units of insulin daily. Insulin resistance of the type manifested by greatly increased insulin requirements may be due to factors including antibody formation although some diseases, such as infections, endocrine hyperfunctional states (e.g. acromegaly, Cushing's syndrome, thyrotoxicosis) or stress can contribute to insulin resistance.

Insulin requirements may decrease with liver disease, disease of the adrenal, pituitary or thyroid glands and coeliac disease. In patients with severe renal impairment, insulin requirements may fall and dosage reduction may be necessary. The compensatory response to hypoglycaemia may also be impaired.

Insulin requirements may be increased in the premenstrual period but may be reduced during or after a menstrual cycle.

Insulin requirements are usually reduced but occasionally increased during periods of increased activity.

Increase in subcutaneous blood flow, brought about by factors such as a hot bath, may increase the rate of absorption of insulin.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Drugs that may increase the requirement for insulin

Antipyschotics: chloropromazine

Corticosteroids

Diazoxide

Diuretics: thiazide diuretics or loop diuretics

Sympathomimetic agents

Thyroid hormone replacement therapy

Smoking may also antagonise the hypoglycaemic effect of insulin

Drugs that may decrease the requirement for insulin

ACE inhibitors

Alcohol: moderate or large amounts of alcohol (more than 2 units per day for women and more than 3 units per day for men) can decrease the requirements for insulin and may lead to hypoglycaemic attacks. Episodic heavy drinking ('binge' drinking) carries a particularly high risk of hypoglycaemic episodes.

Anabolic steroids

Analgesics:NSAIDS, or salicylates, particularly large doses of aspirin

Androgens: testosterone may enhance the hypoglycaemic effect of insulin

Anti-arrhythmics: disopyramide.

Concomitant use of insulin with quinidine may increase the risk of hypoglycaemia occurring.

Anti-depressants: monoamine oxidase inhibitors or fluoxetine.

Concomitant use of amitriptyline with insulin may lead to hypoglycaemia.

Antihypertensives: guanethidine

Antimalarials: concomitant use of insulin with antimalarials such as chloroquine or quinine may increase the risk of hypoglycaemia occurring.

Fenfluramine

Hormone antagonists: octreotide

Lipid-regulating drugs: fibrates

Mebendazole

Pentoxifylline: the hypoglycaemic activity of insulin may be potentiated by concomitant administration of high-dose pentoxifylline injection.

Tetracyclines: tetracyclines such as oxytetracycline

Drugs that may increase or decrease the requirements for insulin

Antihypertensives: clonidine. Signs and symptoms of hypoglycaemia may be masked by clonidine.

Beta blockers: beta blockers. Some of the warning signs of insulin-induced hypoglycaemia may be masked.

Calcium channel blockers: nifedipine may occasionally impair glucose tolerance.

Cyclophosphamide

Isoniazid

Lipid-regulating drugs: gemfibrozil

Oral contraceptives

4.6 Pregnancy And Lactation

Pregnancy

A decreased requirement for insulin may be observed in the early stages of pregnancy. However, in the second and third trimesters, insulin requirements may increase. Insulin requirements should therefore be assessed frequently by an experienced diabetic physician.

Maternal insulin requirements may decrease after delivery. As this decrease can be at an unpredictable rate, the maternal blood glucose should be closely monitored.

Congenital abnormality is more common in offspring of diabetic than non-diabetic women.

Lactation

Caution should be exercised when prescribing to lactating women. Lactating women may require adjustments in insulin dose and diet.

4.7 Effects On Ability To Drive And Use Machines

The patient's ability to concentrate and react may be impaired as a result of hypoglycaemia. This may constitute a risk in situations where these abilities are of special importance (e.g. driving a car or operating machinery).

Patients should be advised to take precautions to avoid hypoglycaemia whilst driving, this is particularly important in those who have reduced or absent awareness of the warning signs of hypoglycaemia or have frequent episodes of hypoglycaemia. The advisability of driving should be considered in these circumstances.

4.8 Undesirable Effects

Metabolic disorders:

• Hypoglycaemia is the most common adverse effect associated with insulin therapy. For symptoms of hypoglycaemia, refer to section 4.9, Overdosage.

• Hypokalaemia may occur with insulin therapy.

• Insulin therapy may lead to weight gain.

General disorders and administration site conditions:

Lipodystrophy (atrophy or hypertrophy of the fat tissue) may occur at the injection site. Stinging or sensations of warmth or burning at the site of injection may also occur.

Immune system disorders:

Insulin hypersensitivity can occur with animal insulins, but appears less likely with purified insulins and there is minimal evidence that such effects occur with Hypurin insulins. Allergic reactions to phenol and m-cresol contained as preservative and to zinc and protamine may occur.

• Local hypersensitivity: Local allergic reactions to insulin such as pruritus, erythema and oedema may occur at the injection site.

• Generalised hypersensitivity: Generalised hypersensitivity may produce urticaria, nausea, dyspnoea or wheezing and, in rare cases, anaphylactic reactions. Severe, angioedema is a rare adverse effect of insulin treatment occurring most often at the initiation of therapy.

4.9 Overdose

a) Symptoms

Overdosage causes hypoglycaemia. Symptoms include yawning, hunger, pallor, restlessness, weakness, sweating, trembling, confusion, anxiety, nervousness, excitement, irritability, aggression, altered behaviour, deep respiration, cramps, headache, paraesthesia and/or numbness of the nose, mouth, fingers or toes, reduced consciousness, visual disturbance, including blurred vision and double vision, slurred speech, difficulty in finding words, difficulty in concentration, drowsiness, fatigue, convulsions, hemiplegia, paralysis, tachycardia and/or palpitations, myocardial ischaemia and cerebral oedema which, if untreated, will lead to collapse, coma and/or irreversible brain damage.

Hypokalaemia may also occur with insulin overdose.

b) Treatment

Mild hypoglycaemia will respond to oral administration of glucose or sugar and rest.

Moderately severe hypoglycaemia can be treated by intramuscular or subcutaneous injection of glucagon followed by oral carbohydrate when the patient is sufficiently recovered.

For patients who are comatose or who have failed to respond to glucagon injection an intravenous injection of strong Dextrose Injection BP should be given.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

ATC Code – A10A A

Insulin output from the pancreas of a healthy person is about 50 units per day, which is sufficient to maintain the fasting blood sugar concentration in the range 0.8 + 0.2mg/ml. In diabetes mellitus, the blood sugar rises in an uncontrolled manner. Parenterally administered insulin causes a fall in blood sugar concentration and increased storage of glycogen in the liver. In the diabetic it raises the respiratory quotient after a carbohydrate meal and prevents the formation of ketone bodies. The rise in blood sugar concentration caused by adrenaline and corticosteroids, glucagon and posterior pituitary extract is reversed by insulin.

5.2 Pharmacokinetic Properties

Insulin is rapidly absorbed from subcutaneous tissue or muscle following injection.

Insulin is metabolised mainly in the liver and a small amount is excreted in the urine.

The plasma half life is 4 to 5 minutes. The half life after subcutaneous injection is about 4 hours and after intramuscular injection about 2 hours.

5.3 Preclinical Safety Data

There are no preclinical data of relevance to the prescriber which are additional to those already included in other sections.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Protamine sulphate

Zinc chloride

m-Cresol

Phenol

Sodium phosphate

Glycerol

Water for injections

6.2 Incompatibilities

None

6.3 Shelf Life

36 months.

Following injection of the first dose the product should be used within 28 days. Discard any unused material after this time.

6.4 Special Precautions For Storage

Store at 2oC - 8oC.

Do not freeze.

Chemical and physical in-use stability has been demonstrated for 28 days at 25°C

From a microbiological point of view the opening carries a risk of microbial contamination and aseptic handling is a necessity.

In use storage times and conditions are the responsibility of the user.

6.5 Nature And Contents Of Container

10ml neutral glass vial sealed with a rubber bung and metal closure.

6.6 Special Precautions For Disposal And Other Handling

Prior to use the vial of Hypurin® Porcine Isophane should be rolled gently between the palms or inverted several times.

The vial must not be used if the contents have been frozen or it contains lumps that do not disperse on mixing.

Hypurin® Porcine Isophane may be mixed with Hypurin® Porcine Neutral in the syringe, in which case Hypurin® Porcine Neutral should be the first dose to be withdrawn. The injection should then be made immediately upon withdrawal of the contents.

The use of each vial should be restricted to a single patient.

7. Marketing Authorisation Holder

Wockhardt UK Ltd

Ash Road North

Wrexham

LL13 9UF

U.K.

8. Marketing Authorisation Number(S)

PL 29831/0121

9. Date Of First Authorisation/Renewal Of The Authorisation

9th April 2008

10. Date Of Revision Of The Text

23 June 2011

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CaviRinse Sodium Fluoride Oral Rinse

Dosage Form: oral mouthwash
CaviRinse™
0.2% Sodium Fluoride Oral Rinse DESCRIPTION:

CaviRinse oral rinse is a prescription formulation for use in the prevention of dental caries. This formulation contains 0.2% sodium fluoride in a neutral pH base to help prevent caries and enhance remineralization.

ACTIVE INGREDIENT: Sodium Fluoride 0.2% w/v.

INACTIVE INGREDIENTS: Water, Glycerine, Microdent® (Ultramulsion® of dimethicone and poloxamer), sodium saccharin, flavoring, cetylpyridinum chloride.

CLINICAL PHARMACOLOGY:

The use of higher-concentration fluoride products results in greater reductions in the incidence of dental caries. CaviRinse oral rinse provides enhanced remineralization of demineralized enamel and enhanced protection against subsequent acid challenges.

INDICATIONS AND USAGE:

CaviRinse oral rinse is indicated for use as part of a professional program for the prevention and control of dental caries. CaviRinse oral rinse should be swished vigorously between your teeth once weekly after brushing with conventional toothpaste, unless otherwise instructed by a dental professional.

CONTRAINDICATIONS:

Do not use in children less than 6 years of age unless recommended by a dental professional.

WARNINGS:

DO NOT SWALLOW. Keep out of reach of children. Frequent ingestion may result in dental fluorosis in children less than 6 years of age, especially if community water fluoridation exceeds 0.6ppm fluoride ion. Use in children less than 6 years of age requires special supervision to prevent swallowing. Carefully read all instructions before using this product.

ADVERSE REACTIONS:

Allergic reactions and other idiosyncrasies have been rarely reported.

OVERDOSAGE:

Medical attention should be sought if more than a standard dose is accidentally swallowed. A single 10ml application of CaviRinse oral rinse contains approximately 9mg of fluoride ion.

DOSAGE AND ADMINISTRATION:

Follow these instructions unless otherwise instructed by a dental professional. Use once weekly after brushing your teeth with a toothpaste. Pour 10ml of CaviRinse oral rinse into the dosage cup, vigorously swish between your teeth for one minute and then spit out. Children 6 to 16 years of age should thoroughly rinse mouth with water.

HOW SUPPLIED:

8oz (236.59ml) of rinse in a plastic bottle with dosage cup.

STORAGE: Do not freeze or expose to extreme heat.

Rx Only

Vanilla Mint Flavor – NDC 48878-3223-8

Made in U.S.A. by
3M ESPE
Dental Products
St. Paul, MN 55144-1000 U.S.A.
1-800-634-2249

CaviRinse is a trademark of 3M or 3M ESPE AG. MICRODENT and ULTRAMULSION are registered trademarks of Whitehill Oral Technologies, Inc.

© 3M 2010. All rights reserved.

Principal Display Panel – Carton Label

NDC 48878-3223-8

Mint

3M ESPE

CaviRinse™

0.2 % Sodium Fluoride

Oral Rinse

Rx Only

Keep out of reach of children.

IMPORTANT: Read

directions thoroughly.

OMNI™

Contents:

8 fl oz

(236.59ml)

Principal Display Panel – Bottle Label

NDC 48878-3223-8

Mint

3M ESPE

CaviRinse™

0.2 % Sodium Fluoride

Oral Rinse

Rx Only

Keep out of reach of children.

IMPORTANT: Read

directions thoroughly.

OMNI™

Contents:

8 fl oz

(236.59ml)

CAVIRINSE 
sodium fluoride  mouthwash Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 48878-3223 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength sodium fluoride (fluoride ion) sodium fluoride 2 mg  in 1 mL Inactive Ingredients Ingredient Name Strength water   glycerin   saccharin sodium   cetylpyridinium chloride anhydrous   Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 48878-3223-8 1 BOTTLE In 1 BOX contains a BOTTLE 1 236.59 mL In 1 BOTTLE This package is contained within the BOX (48878-3223-8)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/01/2005
Labeler - 3M ESPE Dental Products (799975909) Establishment Name Address ID/FEI Operations 3M ESPE Dental Products 799975909 MANUFACTURE Revised: 08/20093M ESPE Dental Products
More CaviRinse Sodium Fluoride Oral Rinse resources CaviRinse Sodium Fluoride Oral Rinse Use in Pregnancy & Breastfeeding CaviRinse Sodium Fluoride Oral Rinse Support Group 3 Reviews for CaviRinse Sodium Fluoride Oral - Add your own review/rating Compare CaviRinse Sodium Fluoride Oral Rinse with other medications Prevention of Dental Caries

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ControlRx Toothpaste

Dosage Form: oral paste, dentifrice
ControlRx™
1.1% Sodium Fluoride Prescription Toothpaste DESCRIPTION:

ControlRx dentifrice is a prescription formulation for use in the prevention of dental caries. This formulation contains 1.1% sodium fluoride in a neutral pH base and a mild abrasive to help remove dental plaque, debris and stain.

ACTIVE INGREDIENT: Sodium Fluoride 1.1% w/w.

INACTIVE INGREDIENTS: Water, Sorbitol, Hydrated Silica, Glycerin, MICRODENT® 2.0% w/w - a patented ULTRAMULSION® of Dimethicone and Poloxamer 407, PEG 12, Flavor, Cellulose Gum, Sodium Lauryl Sulfate, Titanium Dioxide, Sodium Saccharin.

CLINICAL PHARMACOLOGY:

The use of higher-concentration fluoride products results in greater reductions in the incidence of dental caries. ControlRx dentifrice provides enhanced remineralization of demineralized enamel and enhanced protection against subsequent acid challenges, relative to over the counter fluoride products.

INDICATIONS AND USAGE:

ControlRx dentifrice is indicated for use as part of a professional program for the prevention and control of dental caries. ControlRx dentifrice is applied to the teeth using a toothbrush. ControlRx dentifrice should be used once daily in place of a conventional toothpaste, unless otherwise instructed by a dental professional.

CONTRAINDICATIONS:

Do not use in children less than 6 years of age unless recommended by a dental professional.

WARNINGS:

Do not swallow. Keep out of reach of children. Frequent ingestion may result in dental fluorosis in children less than 6 years of age, especially if community water fluoridation exceeds 0.6 ppm fluoride ion. Use in children less than 6 years of age requires special supervision to prevent swallowing. Carefully read all instructions before using this product.

ADVERSE REACTIONS:

Allergic reactions and other idiosyncrasies have been rarely reported.

OVERDOSAGE:

Medical attention should be sought if more than a thin ribbon or pea-sized amount is accidentally swallowed. A thin ribbon or pea-sized amount of ControlRx dentifrice weighs approximately 0.3g and contains approximately 1.5mg of fluoride ion. A 2 oz tube contains 282mg of fluoride ion.

DOSAGE AND ADMINISTRATION:

Follow these instructions unless otherwise instructed by a dental professional. Use once daily.

Apply a thin ribbon or pea-sized amount of ControlRx dentifrice to a soft-bristled toothbrush, and brush teeth for two minutes. After brushing, adults should expectorate. Children 6 to 16 years of age should expectorate and thoroughly rinse mouth with water.

HOW SUPPLIED:

2 oz (57g) net wt. of paste in laminate tubes.

STORAGE: Do not freeze or expose to extreme heat.

Rx Only

Refreshing Berry Flavor: 2 oz tube - NDC 48878-3101-6.

MICRODENT and ULTRAMULSION are registered trademarks of Whitehill Oral Technologies, Inc.

Principal Display Panel – Box Label

3M ESPE

NDC 48878-3101-6

ControlRx™

Berry

1.1% Sodium Fluoride

5000 ppm F- Prescription ToothpasteOMNI™

Rx Only

Contents: 1 Tube

NET WT 2oz (57g)

Principal Display Panel – Tube Label

3M ESPE

NDC 48878-3101-6

ControlRx™

Berry

1.1% Sodium Fluoride

5000 ppm F- Prescription Toothpaste

Rx Only

OMNI™

NET WT

2oz (57g)

CONTROLRX 
sodium fluoride  paste, dentifrice Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 48878-3101 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength sodium fluoride (fluoride ion) sodium fluoride 11 mg  in 1 g Inactive Ingredients Ingredient Name Strength Water   Sorbitol   Silicon Dioxide   Glycerin   Dimethicone   Poloxamer 407   Polyethylene Glycol   Carboxymethylcellulose Sodium   Sodium Lauryl Sulfate   Titanium Dioxide   Saccharin Sodium   Product Characteristics Color      Score      Shape Size Flavor BERRY (BERRY) Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 48878-3101-6 1 TUBE In 1 BOX contains a TUBE 1 57 g In 1 TUBE This package is contained within the BOX (48878-3101-6)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 01/01/2005
Labeler - 3M ESPE Dental Products (799975909) Revised: 05/20103M ESPE Dental Products
More ControlRx Toothpaste resources ControlRx Toothpaste Use in Pregnancy & BreastfeedingControlRx Toothpaste Support Group3 Reviews for ControlRx Toothpaste - Add your own review/rating Compare ControlRx Toothpaste with other medications Prevention of Dental Caries

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Fluorishield

Dosage Form: dental gel
UNFLAVORED Fluorishield BRAND OF 1.1% Sodium Fluoride Dental Gel

Your dentist has selected for you Fluorishield, a 1.1% Sodium Fluoride product that was specially developed to prevent tooth decay which can occur from xerostomia (dry mouth). Dry mouth can result from radiation therapy, systemic diseases, medications which affect the salivary glands and mouth breathing. Clinical trials have shown that application of topical fluoride gel in the presence of good oral hygiene can prevent or significantly reduce tooth decay which is related to dry mouth.  Fluorishield topical fluoride gel can be applied with a custom carrier or tray, directly brushed on, or used with an over denture. Your dentist will prescribe the method that is best suited for your individual needs. The gel is easily dispensed when the bottle is inverted for storing.

STORE INVERTED FOR EASY REMOVAL OF CONTENTS.

Description:

Topical neutral 1.1% sodium fluoride for use as a dental caries preventative in children and adults. This prescription product is not a dentifrice.

Warnings:

DO NOT SWALLOW. As with all medications, this product should be kept out of reach of children.

Overdose:

Accidental ingestion of a usual treatment dose (1-2mgF) is not harmful.

Store at temperature between 68?-77?F (20?-25?C).

CAUTION:

Federal (U.S.A.) law prohibits dispensing without a prescription.

INSTRUCTIONS Custom Carriers or Trays

Brush and floss your teeth to remove plaque. Adults and children 6 years of age or older: Add one drop of Fluorishield into each tooth area in the custom carrier and spread evenly with the applicator tip of the fluoride bottle. Place carriers over the teeth and let it remain in place for one (1) minute or longer (as directed by your doctor). Expectorate the excess gel.  Clean carriers with cold water. Spit out the excess gel in the mouth and do not rinse, eat, or drink for thirty (30) minutes.

Brush On

Brush and floss your teeth to remove plaque. Adults and children 6 years of age or older: Apply a thin ribbon of gel to the toothbrush and spread evenly with the applicator tip of the fluoride bottle. Brush all tooth surfaces and allow fluoride to remain in place for one (1) minute or longer (as directed by your doctor). Clean carriers with cold water. Expectorate the excess gel in the mouth and do not rinse, eat, or drink for thirty (30) minutes.

Overdentures

Brush all tooth surfaces.  Clean your dentures. Adults and children 6 years of age or older: Apply one (1) or two (2)drops of Fluorishield to each tooth area in your denture and place the dentures in your mouth. Leave in place for one (1) minute or longer (as directed by your doctor).Expectorate the excess gel in the mouth and do not rinse, eat, or drink for thirty (30) minutes.

™

MEDICAL PRODUCTS LABORATORIES, INC.

9990 Global Road • Phila., PA 19115-1083 800-523-0191 fax 215-677-7736 www.mplusa.com

Fluorishield 
sodium fluoride  gel Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 10733-130 Route of Administration DENTAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE 11 mg  in 1 g Inactive Ingredients Ingredient Name Strength WATER   SACCHARIN SODIUM   HYDROXYETHYL CELLULOSE (4000 MPA.S FOR 1% AQUEOUS SOLUTION)   Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 10733-130-04 66 BOTTLE In 1 CARTON contains a BOTTLE 1 114 g In 1 BOTTLE This package is contained within the CARTON (10733-130-04)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 11/29/2009
Labeler - Medical Products Laboratories, Inc. (002290302) Revised: 02/2011Medical Products Laboratories, Inc.
More Fluorishield resources Fluorishield Use in Pregnancy & Breastfeeding Fluorishield Support Group 3 Reviews for Fluorishield - Add your own review/rating Compare Fluorishield with other medications Prevention of Dental Caries

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Hypurin Porcine 30 / 70 Mix Cartridges

1. Name Of The Medicinal Product

Hypurin® Porcine 30/70 Mix

2. Qualitative And Quantitative Composition

Crystalline Insulin Ph Eur (Porcine) 100 IU/ml.

Biphasic Isophane Insulin Injection Ph Eur 100 iu/ml (Porcine)

For excipients see 6.1.

3. Pharmaceutical Form

Suspension for injection.

A white suspension

4. Clinical Particulars 4.1 Therapeutic Indications

The treatment of insulin dependent diabetes mellitus.

May be used for diabetics requiring a depot insulin of intermediate duration.

4.2 Posology And Method Of Administration

To be determined by the physician according to the needs of the patient.

Usually administered subcutaneously but where necessary it may be given intramuscularly in which case onset is more rapid and overall duration shorter. It should not be given intravenously. Onset of action occurs within 2 hours after subcutaneous injection with an overall duration up to 24 hours. Maximum effect is exerted between 4-12 hours.

4.3 Contraindications

Hypoglycaemia.

Hypersensitivity to insulin or to any of the excipients.

4.4 Special Warnings And Precautions For Use

In no circumstances must Hypurin® Porcine 30/70 Mix be given intravenously.

Hypoglycaemia: Susceptibility to hypoglycaemia may be increased by an inaccurate or excessive dosage of insulin, the omission of a meal by the patient or increased physical activity. Correct insulin administration and awareness of the symptoms of hypoglycaemia are essential to reduce the risk of hypoglycaemia (see section 4.9).

Blood or urinary glucose concentrations should be monitored and the urine tested for ketones by patients on insulin therapy.

Newly diagnosed diabetic patients may experience fluctuating insulin requirements during the first weeks, months or even years of treatment (the so-called 'honeymoon period').

Patients transferred to Hypurin® Porcine insulins from other commercially available preparations may require dosage adjustments.

The warning symptoms of hypoglycaemia may be changed, be less pronounced or absent in certain risk groups who should be advised accordingly. These include patients:

- in whom glycaemic control is greatly improved, e.g. by intensified insulin therapy

- with a long history of diabetes

- who are elderly

- receiving concomitant treatment with certain medicinal products e.g. beta blockers or clonidine.

Elderly diabetic patients are more susceptible to episodes of severe, rapid onset hypoglycaemia.

Combination of Hypurin® insulins with pioglitazone: Cases of cardiac failure have been reported when thiazolidinediones are used in combination with insulin, especially in patients with risk factors for development of cardiac heart failure. This should be kept in mind if treatment with the combination of pioglitazone and Hypurin® is considered. If the combination is used, patients should be observed for signs and symptoms of heart failure, weight gain and oedema. Pioglitazone should be discontinued if any deterioration in cardiac symptoms occurs.

Insulin requirements may increase during illness (this includes infection and accidental and surgical trauma), puberty or emotional upset.

Insulin resistance is frequently associated with lipid disorders, hypertension and ischaemic heart disease. Patients with insulin resistance usually require more than 200 units of insulin daily. Insulin resistance of the type manifested by greatly increased insulin requirements may be due to factors including antibody formation although some diseases, such as infections, endocrine hyperfunctional states (e.g. acromegaly, Cushing's syndrome, thyrotoxicosis) or stress can contribute to insulin resistance.

Insulin requirements may decrease with liver disease, disease of the adrenal, pituitary or thyroid glands and coeliac disease. In patients with severe renal impairment, insulin requirements may fall and dosage reduction may be necessary. The compensatory response to hypoglycaemia may also be impaired.

Insulin requirements may be increased in the premenstrual period but may be reduced during or after a menstrual cycle.

Insulin requirements are usually reduced but occasionally increased during periods of increased activity.

Increase in subcutaneous blood flow, brought about by factors such as a hot bath, may increase the rate of absorption of insulin.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Drugs that may increase the requirement for insulin

Antipyschotics: chloropromazine

Corticosteroids

Diazoxide

Diuretics: thiazide diuretics or loop diuretics

Sympathomimetic agents

Thyroid hormone replacement therapy

Smoking may also antagonise the hypoglycaemic effect of insulin

Drugs that may decrease the requirement for insulin

ACE inhibitors

Alcohol: moderate or large amounts of alcohol (more than 2 units per day for women and more than 3 units per day for men) can decrease the requirements for insulin and may lead to hypoglycaemic attacks. Episodic heavy drinking ('binge' drinking) carries a particularly high risk of hypoglycaemic episodes.

Anabolic steroids

Analgesics: NSAIDS, or salicylates, particularly large doses of aspirin

Androgens: testosterone may enhance the hypoglycaemic effect of insulin

Anti-arrhythmics: disopyramide.

Concomitant use of insulin with quinidine may increase the risk of hypoglycaemia occurring.

Anti-depressants: monoamine oxidase inhibitors or fluoxetine.

Concomitant use of amitriptyline with insulin may lead to hypoglycaemia.

Antihypertensives: guanethidine

Antimalarials: concomitant use of insulin with antimalarials such as chloroquine or quinine may increase the risk of hypoglycaemia occurring.

Fenfluramine

Hormone antagonists: octreotide

Lipid-regulating drugs: fibrates

Mebendazole

Pentoxifylline: the hypoglycaemic activity of insulin may be potentiated by concomitant administration of high-dose pentoxifylline injection.

Tetracyclines: tetracyclines such as oxytetracycline

Drugs that may increase or decrease the requirements for insulin

Antihypertensives: clonidine. Signs and symptoms of hypoglycaemia may be masked by clonidine.

Beta blockers: beta blockers. Some of the warning signs of insulin-induced hypoglycaemia may be masked.

Calcium channel blockers: nifedipine may occasionally impair glucose tolerance.

Cyclophosphamide

Isoniazid

Lipid-regulating drugs: gemfibrozil

Oral contraceptives

4.6 Pregnancy And Lactation

Pregnancy

A decreased requirement for insulin may be observed in the early stages of pregnancy. However, in the second and third trimesters, insulin requirements may increase. Insulin requirements should therefore be assessed frequently by an experienced diabetic physician.

Maternal insulin requirements may decrease after delivery. As this decrease can be at an unpredictable rate, the maternal blood glucose should be closely monitored.

Congenital abnormality is more common in offspring of diabetic than non-diabetic women.

Lactation

Caution should be exercised when prescribing to lactating women. Lactating women may require adjustments in insulin dose and diet.

4.7 Effects On Ability To Drive And Use Machines

The patient's ability to concentrate and react may be impaired as a result of hypoglycaemia. This may constitute a risk in situations where these abilities are of special importance (e.g. driving a car or operating machinery).

Patients should be advised to take precautions to avoid hypoglycaemia whilst driving, this is particularly important in those who have reduced or absent awareness of the warning signs of hypoglycaemia or have frequent episodes of hypoglycaemia. The advisability of driving should be considered in these circumstances.

4.8 Undesirable Effects

Metabolic disorders:

• Hypoglycaemia is the most common adverse effect associated with insulin therapy. For symptoms of hypoglycaemia, refer to section 4.9, Overdosage.

• Hypokalaemia may occur with insulin therapy.

• Insulin therapy may lead to weight gain.

General disorders and administration site conditions:

Lipodystrophy (atrophy or hypertrophy of the fat tissue) may occur at the injection site. Stinging or sensations of warmth or burning at the site of injection may also occur.

Immune system disorders:

Insulin hypersensitivity can occur with animal insulins, but appears less likely with purified insulins and there is minimal evidence that such effects occur with Hypurin insulins. Allergic reactions to phenol and m-cresol contained as preservative and to zinc and protamine may occur.

• Local hypersensitivity: Local allergic reactions to insulin such as pruritus, erythema and oedema may occur at the injection site.

• Generalised hypersensitivity: Generalised hypersensitivity may produce urticaria, nausea, dyspnoea or wheezing and, in rare cases, anaphylactic reactions. Severe, angioedema is a rare adverse effect of insulin treatment occurring most often at the initiation of therapy.

4.9 Overdose

a) Symptoms

Overdosage causes hypoglycaemia. Symptoms include yawning, hunger, pallor, restlessness, weakness, sweating, trembling, confusion, anxiety, nervousness, excitement, irritability, aggression, altered behaviour, deep respiration, cramps, headache, paraesthesia and/or numbness of the nose, mouth, fingers or toes, reduced consciousness, visual disturbance, including blurred vision and double vision, slurred speech, difficulty in finding words, difficulty in concentration, drowsiness, fatigue, convulsions, hemiplegia, paralysis, tachycardia and/or palpitations, myocardial ischaemia and cerebral oedema which, if untreated, will lead to collapse, coma and/or irreversible brain damage.

Hypokalaemia may also occur with insulin overdose.

b) Treatment

Mild hypoglycaemia will respond to oral administration of glucose or sugar and rest.

Moderately severe hypoglycaemia can be treated by intramuscular or subcutaneous injection of glucagon followed by oral carbohydrate when the patient is sufficiently recovered.

For patients who are comatose or who have failed to respond to glucagon injection an intravenous injection of strong Dextrose Injection BP should be given.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

ATC Code – A10A A

Insulin output from the pancreas of a healthy person is about 50 units per day, which is sufficient to maintain the fasting blood sugar concentration in the range 0.8 ! 0.2mg/ml. In diabetes mellitus, the blood sugar rises in an uncontrolled manner. Parenterally administered insulin causes a fall in blood sugar concentration and increased storage of glycogen in the liver. In the diabetic it raises the respiratory quotient after a carbohydrate meal and prevents the formation of ketone bodies. The rise in blood sugar concentration caused by adrenaline and corticosteroids, glucagon and posterior pituitary extract is reversed by insulin.

5.2 Pharmacokinetic Properties

Insulin is rapidly absorbed from subcutaneous tissue or muscle following injection.

Insulin is metabolised mainly in the liver and a small amount is excreted in the urine.

The plasma half-life is four to five minutes. The half-life after subcutaneous injection is about four hours and after intramuscular injection about two hours.

5.3 Preclinical Safety Data

There are no preclinical data of relevance to the prescriber that are additional to that already included in other sections.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Protamine sulphate

Zinc chloride

m-Cresol

Phenol

Sodium phosphate

Glycerol

Water for injections

6.2 Incompatibilities

None

6.3 Shelf Life

36 months.

Following injection of the first dose the product should be used within 28 days. Discard any unused material after this time.

6.4 Special Precautions For Storage

Store at 2oC - 8oC.

Do not freeze.

Cartridges in use must not be stored in a refrigerator.

Chemical and physical in-use stability has been demonstrated for 28 days at 25°C.

From a microbiological point of view the opening carries a risk of microbial contamination and aseptic handling is a necessity.

In use storage times and conditions are the responsibility of the user.

6.5 Nature And Contents Of Container

1.5ml neutral glass cartridge sealed with a bromobutyl rubber bung and metal closure in packs of five.

3ml neutral glass cartridge sealed with a bromobutyl rubber bung and metal closure in packs of five.

6.6 Special Precautions For Disposal And Other Handling

Prior to insertion in the pen the cartridge of Hypurin® Porcine 30/70 Mix should be shaken vigorously up and down, with a “bell ringing” action, at least ten times.

Immediately before each injection the pen should be inverted at least ten times to mix the insulin again.

The cartridge must not be used if the contents have been frozen or it contains lumps that do not disperse on mixing.

7. Marketing Authorisation Holder

Wockhardt UK Ltd

Ash Road North

Wrexham

LL13 9UF

U.K.

8. Marketing Authorisation Number(S)

PL 29831/0119

9. Date Of First Authorisation/Renewal Of The Authorisation

8th April 2008

10. Date Of Revision Of The Text

23 June 2011

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Hypurin Bovine Lente

1. Name Of The Medicinal Product

Hypurin® Bovine Lente 100 IU/ml injection

2. Qualitative And Quantitative Composition

Crystalline Insulin Ph Eur (Bovine) 100 IU/ml.

Insulin Zinc Suspension (Mixed) Ph Eur (Bovine)

For excipients, see 6.1

3. Pharmaceutical Form

Suspension for injection.

A white suspension

4. Clinical Particulars 4.1 Therapeutic Indications

The treatment of insulin dependent diabetes mellitus.

Hypurin® Bovine Lente may be used for diabetics requiring a depot insulin of medium to extended duration.

4.2 Posology And Method Of Administration

To be determined by the physician according to the needs of the patient.

Administered subcutaneously. It is not recommended for intramuscular use and should not be given intravenously. Onset of action occurs approximately 2 hours after subcutaneous injection with an overall duration extending up to 30 hours. Maximum effect is exerted between 8-12 hours.

Prior to use, the vial of Hypurin® Bovine Lente should be rolled gently between the palms or inverted several times.

4.3 Contraindications

Hypoglycaemia.

Hypersensitivity to insulin or to any of the excipients.

4.4 Special Warnings And Precautions For Use

In no circumstances must Hypurin® Bovine Lente be given intravenously.

Hypoglycaemia: Susceptibility to hypoglycaemia may be increased by an inaccurate or excessive dosage of insulin, the omission of a meal by the patient or increased physical activity. Correct insulin administration and awareness of the symptoms of hypoglycaemia are essential to reduce the risk of hypoglycaemia (see section 4.9).

Blood or urinary glucose concentrations should be monitored and the urine tested for ketones by patients on insulin therapy.

Newly diagnosed diabetic patients may experience fluctuating insulin requirements during the first weeks, months or even years of treatment (the so-called 'honeymoon period').

Patients transferred to Hypurin® Bovine insulins from other commercially available preparations may require dosage adjustments.

The warning symptoms of hypoglycaemia may be changed, be less pronounced or absent in certain risk groups who should be advised accordingly. These include patients:

- in whom glycaemic control is greatly improved, e.g. by intensified insulin therapy

- with a long history of diabetes

- who are elderly

- receiving concomitant treatment with certain medicinal products e.g. beta blockers or clonidine.

Elderly diabetic patients are more susceptible to episodes of severe, rapid onset hypoglycaemia.

Combination of Hypurin® insulins with pioglitazone: Cases of cardiac failure have been reported when thiazolidinediones are used in combination with insulin, especially in patients with risk factors for development of cardiac heart failure. This should be kept in mind if treatment with the combination of pioglitazone and Hypurin® is considered. If the combination is used, patients should be observed for signs and symptoms of heart failure, weight gain and oedema. Pioglitazone should be discontinued if any deterioration in cardiac symptoms occurs.

Insulin requirements may increase during illness (this includes infection and accidental and surgical trauma), puberty or emotional upset.

Insulin resistance is frequently associated with lipid disorders, hypertension and ischaemic heart disease. Patients with insulin resistance usually require more than 200 units of insulin daily. Insulin resistance of the type manifested by greatly increased insulin requirements may be due to factors including antibody formation although some diseases, such as infections, endocrine hyperfunctional states (e.g. acromegaly, Cushing's syndrome, thyrotoxicosis) or stress can contribute to insulin resistance.

Insulin requirements may decrease with liver disease, disease of the adrenal, pituitary or thyroid glands and coeliac disease. In patients with severe renal impairment, insulin requirements may fall and dosage reduction may be necessary. The compensatory response to hypoglycaemia may also be impaired.

Insulin requirements may be increased in the premenstrual period but may be reduced during or after a menstrual cycle.

Insulin requirements are usually reduced but occasionally increased during periods of increased activity.

Increase in subcutaneous blood flow, brought about by factors such as a hot bath, may increase the rate of absorption of insulin.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Drugs that may increase the requirement for insulin

Antipyschotics: chloropromazine

Corticosteroids

Diazoxide

Diuretics: thiazide diuretics or loop diuretics

Sympathomimetic agents

Thyroid hormone replacement therapy

Smoking may also antagonise the hypoglycaemic effect of insulin

Drugs that may decrease the requirement for insulin

ACE inhibitors

Alcohol: moderate or large amounts of alcohol (more than 2 units per day for women and more than 3 units per day for men) can decrease the requirements for insulin and may lead to hypoglycaemic attacks. Episodic heavy drinking ('binge' drinking) carries a particularly high risk of hypoglycaemic episodes.

Anabolic steroids

Analgesics: NSAIDS, or salicylates, particularly large doses of aspirin

Androgens: testosterone may enhance the hypoglycaemic effect of insulin

Anti-arrhythmics: disopyramide.

Concomitant use of insulin with quinidine may increase the risk of hypoglycaemia occurring.

Anti-depressants: monoamine oxidase inhibitors or fluoxetine.

Concomitant use of amitriptyline with insulin may lead to hypoglycaemia.

Antihypertensives: guanethidine

Antimalarials: concomitant use of insulin with antimalarials such as chloroquine or quinine may increase the risk of hypoglycaemia occurring.

Fenfluramine

Hormone antagonists: octreotide

Lipid-regulating drugs: fibrates

Mebendazole

Pentoxifylline: the hypoglycaemic activity of insulin may be potentiated by concomitant administration of high-dose pentoxifylline injection.

Tetracyclines: tetracyclines such as oxytetracycline

Drugs that may increase or decrease the requirements for insulin

Antihypertensives: clonidine. Signs and symptoms of hypoglycaemia may be masked by clonidine.

Beta blockers: beta blockers. Some of the warning signs of insulin-induced hypoglycaemia may be masked.

Calcium channel blockers: nifedipine may occasionally impair glucose tolerance.

Cyclophosphamide

Isoniazid

Lipid-regulating drugs: gemfibrozil

Oral contraceptives

4.6 Pregnancy And Lactation

Pregnancy

A decreased requirement for insulin may be observed in the early stages of pregnancy. However, in the second and third trimesters, insulin requirements may increase. Insulin requirements should therefore be assessed frequently by an experienced diabetic physician.

Maternal insulin requirements may decrease after delivery. As this decrease can be at an unpredictable rate, the maternal blood glucose should be closely monitored.

Congenital abnormality is more common in offspring of diabetic than non-diabetic women.

Lactation

Caution should be exercised when prescribing to lactating women. Lactating women may require adjustments in insulin dose and diet.

4.7 Effects On Ability To Drive And Use Machines

The patient's ability to concentrate and react may be impaired as a result of hypoglycaemia. This may constitute a risk in situations where these abilities are of special importance (e.g. driving a car or operating machinery).

Patients should be advised to take precautions to avoid hypoglycaemia whilst driving, this is particularly important in those who have reduced or absent awareness of the warning signs of hypoglycaemia or have frequent episodes of hypoglycaemia. The advisability of driving should be considered in these circumstances.

4.8 Undesirable Effects

Metabolic disorders:

• Hypoglycaemia is the most common adverse effect associated with insulin therapy. For symptoms of hypoglycaemia, refer to section 4.9, Overdosage.

• Hypokalaemia may occur with insulin therapy.

• Insulin therapy may lead to weight gain.

General disorders and administration site conditions:

Lipodystrophy (atrophy or hypertrophy of the fat tissue) may occur at the injection site. Stinging or sensations of warmth or burning at the site of injection may also occur.

Immune system disorders:

Insulin hypersensitivity can occur with animal insulins, but appears less likely with purified insulins and there is minimal evidence that such effects occur with Hypurin insulins. Allergic reactions to phenol and m-cresol contained as preservative and to zinc and protamine may occur.

• Local hypersensitivity: Local allergic reactions to insulin such as pruritus, erythema and oedema may occur at the injection site.

• Generalised hypersensitivity: Generalised hypersensitivity may produce urticaria, nausea, dyspnoea or wheezing and, in rare cases, anaphylactic reactions. Severe, angioedema is a rare adverse effect of insulin treatment occurring most often at the initiation of therapy.

4.9 Overdose

a) Symptoms

Overdosage causes hypoglycaemia. Symptoms include yawning, hunger, pallor, restlessness, weakness, sweating, trembling, confusion, anxiety, nervousness, excitement, irritability, aggression, altered behaviour, deep respiration, cramps, headache, paraesthesia and/or numbness of the nose, mouth, fingers or toes, reduced consciousness, visual disturbance, including blurred vision and double vision, slurred speech, difficulty in finding words, difficulty in concentration, drowsiness, fatigue, convulsions, hemiplegia, paralysis, tachycardia and/or palpitations, myocardial ischaemia and cerebral oedema which, if untreated, will lead to collapse, coma and/or irreversible brain damage.

Hypokalaemia may also occur with insulin overdose.

b) Treatment

Mild hypoglycaemia will respond to oral administration of glucose or sugar and rest.

Moderately severe hypoglycaemia can be treated by intramuscular or subcutaneous injection of glucagon followed by oral carbohydrate when the patient is sufficiently recovered.

For patients who are comatose or who have failed to respond to glucagon injection an intravenous injection of strong Dextrose Injection BP should be given.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

ATC Code – A10A A

Insulin output from the pancreas of a healthy person is about 50 units per day, which is sufficient to maintain the fasting blood sugar concentration in the range 0.8 ± 0.2mg/ml. In diabetes mellitus, the blood sugar rises in an uncontrolled manner. Parenterally administered insulin causes a fall in blood sugar concentration and increased storage of glycogen in the liver. In the diabetic it raises the respiratory quotient after a carbohydrate meal and prevents the formation of ketone bodies. The rise in blood sugar concentration caused by adrenaline and corticosteroids, glucagon and posterior pituitary extract is reversed by insulin.

5.2 Pharmacokinetic Properties

Insulin is rapidly absorbed from subcutaneous tissue following injection.

Insulin is metabolised mainly in the liver and a small amount is excreted in the urine.

The plasma half-life is 4 to 5 minutes. The half-life after subcutaneous injection is about 4 hours.

5.3 Preclinical Safety Data

There are no preclinical data of relevance to the prescriber which are additional to those already included in other sections.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Sodium chloride

Sodium acetate

Methylparahydroxybenzoate

Zinc oxide

Water for injections

Hydrochloric acid

Sodium hydroxide

6.2 Incompatibilities

Not applicable

6.3 Shelf Life

Three years.

Following injection of the first dose the product should be used within 28 days. Discard any unused material after this time.

6.4 Special Precautions For Storage

Store at 2oC - 8oC.

Do not freeze.

Chemical and physical in-use stability has been demonstrated for 28 days at 25°C.

From a microbiological point of view the opening carries a risk of microbial contamination and aseptic handling is a necessity.

In use storage times and conditions are the responsibility of the user.

6.5 Nature And Contents Of Container

10ml Type I glass vial sealed with a rubber bung and metal closure.

6.6 Special Precautions For Disposal And Other Handling

The vial must not be used if the contents have been frozen or it contains lumps that do not disperse on mixing.

Prior to use the vial of Hypurin® Bovine Lente should be rolled gently between the palms or inverted several times.

Hypurin® Bovine Lente may be mixed with bovine neutral insulin in the syringe, in which case the bovine neutral insulin should be the first dose to be withdrawn. The injection should then be made immediately upon withdrawal of the contents.

The use of each vial should be restricted to a single patient.

7. Marketing Authorisation Holder

Wockhardt UK Ltd

Ash Road North

Wrexham

LL13 9UF

U.K.

8. Marketing Authorisation Number(S)

PL 29831/0129

9. Date Of First Authorisation/Renewal Of The Authorisation

7th April 2008

10. Date Of Revision Of The Text

23 June 2011

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Atropine Sulphate Injection BP 600mcg / ml

1. Name Of The Medicinal Product

Atropine Sulphate Injection BP 600mcg/ml.

2. Qualitative And Quantitative Composition

Atropine Sulphate BP 0.06% w/v.

3. Pharmaceutical Form

Sterile solution for injection.

4. Clinical Particulars 4.1 Therapeutic Indications

1. Drying secretions prior to anaesthesia.

2. Reversal of excessive bradycardia.

3. Indicated with neostigmine for reversal of neuromuscular block.

4.2 Posology And Method Of Administration

Adults

Bradycardia

Management of bradycardia of acute myocardial infarction: Initial dose 300 – 600mcg intravenously, the dose may be increased by incremental doses of 100mcg up to 1mg if necessary.

Caution is required as atropine may aggravate ischaemia or infarction.

Treatment of bradycardia or asystole due to overdosage with parasympathetic agents:

1-2mg subcutaneously, intramuscularly or intravenously.

Drying secretions

300 – 600mcg subcutaneously or intramuscularly 30 – 60 minutes prior to induction of anaesthesia. Alternatively, 300 – 600mcg may be given intravenously immediately prior to induction of anaesthesia.

Reversal of competitive neuromuscular block

0.6 – 1.2mg by slow intravenous injection for control of muscarinic side effects of neostigmine in reversal of competitive neuromuscular block. Atropine should not be given routinely with neostigmine as it may mask signs of overdose.

Children aged 1 year and over

Caution should be exercised in children and reduced doses are necessary.

Drying secretions: 20mcg/kg intramuscularly 30 – 60 minutes prior to induction of anaesthesia. This dose should be reduced on hot days or in fever.

Other indications are not recommended for children.

Elderly

Caution should be exercised in the elderly and reduced doses may be required.

Routes of administration: Intravenous, intramuscular or subcutaneous injection.

4.3 Contraindications

Known hypersensitivity to atropine, prostatic enlargement, paralytic ileus, pyloric stenosis, closed angle glaucoma or patients with narrow angle between iris and cornea. Atropine should not be given to patients, particularly children, when ambient temperatures are high due to the risk of provoked hyperpyrexia.

4.4 Special Warnings And Precautions For Use

Atropine should be used with caution in children and the elderly, patients with ulcerative colitis as ileus and megacolon may result and those with diarrhoea. Caution is required in patients having a fever, conditions characterised by tachycardia such as thyrotoxicosis, cardiac insufficiency or failure and in cardiac surgery or acute myocardial infarction. Atropine should be given with care to patients with hypertension. Extreme caution is necessary in patients with myasthenia gravis or autonomic neuropathy.

Caution is required when atropine is administered systemically to patients with chronic obstructive pulmonary disease, as a reduction in bronchial secretions may lead to the formation of bronchial plugs.

Antimuscarinics may delay gastric emptying, decrease gastric motility and relax the oesophageal sphincter. They should be used with caution in patients whose conditions may be aggravated by these effects e.g. reflux oesophagitis.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Effects of atropine may be enhanced by concomitant administration of drugs having antimuscarnic properties. The reduction in gastric motility caused by atropine may affect absorption of other drugs.

4.6 Pregnancy And Lactation

Safety in human pregnancy has not been established although atropine does cross the placenta. Atropine may have antimuscarinic effects in infants. Therefore it is not advisable to administer atropine during pregnancy or breast feeding unless considered essential.

4.7 Effects On Ability To Drive And Use Machines

None as used on sedentary patients.

4.8 Undesirable Effects

Common side effects include dryness of the mouth with difficulty in swallowing and talking, thirst, mydriasis with cycloplegia and photophobia, flushing and dryness of skin, transient bradycardia followed by tachycardia, palpitations and arrhythmias, urinary retention, constipation.

Other reported side effects include anaphylaxis, urticaria and rash occasionally progressing to exfoliation.

Occasionally vomiting and dizziness. Retrosternal pain may occur due to gastric reflux. Rare occurrences include confusional states and fever.

Atropine may cause raised intra-ocular pressure and mental confusion especially in the elderly.

4.9 Overdose

Symptoms: Flushing and dryness of the skin (rash may appear on the face and upper trunk), tachycardia, rapid respiration, hyperpyrexia, CNS stimulation (restlessness, confusion, excitement, paranoid and psychotic reactions, hallucinations and delirium and occasionally seizures and convulsions). Severe overdose may be indicated by CNS depression, coma, circulatory and respiratory failure and death.

Treatment: Supportive therapy as necessary. Neostigmine or carbachol antagonise peripheral adverse effects. In children the body surface should be kept moist.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Atropine is an antimuscarinic alkaloid with both central and peripheral actions. It first stimulates and then depresses the central nervous system and has antispasmodic actions on smooth muscle and reduces secretions, especially salivary and bronchial secretions.

5.2 Pharmacokinetic Properties

Rapidly cleared from blood and distributed throughout the body.

Completely metabolised in the liver and excreted in the urine as unchanged drug and metabolites.

Atropine crosses the placenta and traces are found in breast milk. Atropine crosses the blood brain barrier.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Sulphuric Acid BP

Water for Injections HSE

6.2 Incompatibilities

Atropine is incompatible with alkaloids, tannic acid and mercury salts.

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

Store below 25°C.

6.5 Nature And Contents Of Container

1ml neutral glass ampoules in packs of 5, 10 or 100.

6.6 Special Precautions For Disposal And Other Handling

None stated.

7. Marketing Authorisation Holder

Antigen International Limited

Roscrea

Co. Tipperary

Ireland

8. Marketing Authorisation Number(S)

PL 02848/0211

9. Date Of First Authorisation/Renewal Of The Authorisation

3 April 2000

10. Date Of Revision Of The Text

February 2000

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Calcium Chloride BP Sterile Solution (UCB Pharma Limited)

1. Name Of The Medicinal Product

Calcium Chloride BP Sterile Solution

2. Qualitative And Quantitative Composition

Calcium Chloride Dihydrate BP 13.4% w/v

'For excipients, see 6.1'

3. Pharmaceutical Form

Sterile solution for slow intravenous injection.

4. Clinical Particulars 4.1 Therapeutic Indications

Calcium Chloride Sterile Solution is indicated for the treatment of acute hypocalcaemia where there is a requirement for the rapid replacement of calcium, e.g. severe hypocalcaemic tetany or hypoparathyroidism, or where the oral route is inappropriate due to malabsorption.

4.2 Posology And Method Of Administration

Route of Administration: Slow intravenous injection.

Adults

A typical dose is 2.25 to 4.5 mmol of calcium given by slow intravenous injection not exceeding 1 ml per minute and repeated as necessary.

Children

The cause of the hypocalcaemia must be fully assessed before starting therapy including dietary review, measurement of vitamin D and PTH, together with regular serum calcium and phosphate levels. For children with hypocalcaemic tetany a dosage of 0.25 to 0.35 mmol/kg of calcium given by slow intravenous injection may be given, repeated every six to eight hours until a response is seen. For other hypocalcaemia conditions initial doses of 0.5 to 3.5 mmol of calcium may be given to elevate serum calcium concentrations.

Infants

Calcium chloride has been given to infants at doses of under 0.5 mmol of calcium, but calcium gluconate is usually preferred due to the irritancy of calcium chloride.

4.3 Contraindications

Parenteral calcium therapy is contraindicated in patients receiving cardiac glycosides. Unsuitable for the treatment of hypocalcaemia caused by renal insufficiencies.

In cardiac resuscitation, the use of calcium is contraindicated in the presence of ventricular fibrillation.

Ceftriaxone is contraindicated in premature newborns up to a corrected age of 41 weeks (weeks of gestation + weeks of life) and full-term newborns (up to 28 days of age) if they require (or are expected to require) IV calcium treatment, or calcium-containing infusions because of the risk of precipitation of ceftriaxone-calcium (see sections 4.4 and 4.5).

The treatment of asystole and electromechanical dissociation.

Hypersensitivity to any component.

4.4 Special Warnings And Precautions For Use

Calcium chloride can cause gastro-intestinal irritation due to the stimulatory effects of calcium on gastric acid production. However, the effect would be most likely with oral administration.

Close monitoring of serum calcium levels is essential following IV administration of calcium.

Calcium salts should be used with caution in patients with impaired renal function, cardiac disease or sarcoidosis.

Because it is acidifying, calcium chloride should be used cautiously in patients with respiratory acidosis or respiratory failure.

Cases of fatal reactions with calcium-ceftriaxone precipitates in lungs and kidneys in premature and full-term newborns aged less than 1 month have been described. At least one of them had received ceftriaxone and calcium at different times and through different intravenous lines. In the available scientific data, there are no reports of confirmed intravascular precipitations in patients, other than newborns, treated with ceftriaxone and calcium-containing solutions or any other calcium-containing products.

In patients of any age ceftriaxone must not be mixed or administered simultaneously with any calcium-containing IV solutions, even via different infusion lines or at different infusion sites. However, in patients older than 28 days of age ceftriaxone and calcium-containing solutions may be administered sequentially one after another if infusion lines at different sites are used, or if the infusion lines are replaced or thoroughly flushed between infusions with physiological salt-solution to avoid precipitation. In patients requiring continuous infusion with calcium-containing TPN solutions, healthcare professionals may wish to consider the use of alternative antibacterial treatments which do not carry a similar risk of precipitation. If use of ceftriaxone is considered necessary in patients requiring continuous nutrition, TPN solutions and ceftriaxone can be administered simultaneously, albeit via different infusion lines at different sites. Alternatively, infusion of TPN solution could be stopped for the period of ceftriaxone infusion, considering the advice to flush infusion lines between solutions.

Calcium chloride injection is irritating to veins and must not be injected into tissues, since severe necrosis and sloughing may occur. Great care should be taken to avoid extravasation or accidental injection into perivascular tissues. Should perivascular infiltration occur, IV administration at that site should be discontinued at once. Local infiltration of the affected area with 1 % procaine hydrochloride, to which hyaluronidase may be added, will often reduce venospasm and dilute the calcium remaining in the tissues locally. Local application of heat may also be helpful.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

For interaction between calcium containing products and ceftriaxone, please see sections 4.3 and 4.4 above.

Calcium-containing products may decrease the effectiveness of calcium channel blockers.

Calcium salts reduce the absorption of a number of drugs such as bisphosphonates, fluoride, some fluoroquinolones and tetracyclines; administration should be separated by at least 3 hours.

Calcium chloride infusion reduces the cardiotonic effects of dobutamine.

The effects of digitalis can be increased by increases in blood calcium levels, and the administration of intravenous calcium may result in the development of potentially life-threatening digitalis induced heart arrhythmias.

Thiazide diuretics decrease urinary calcium excretion, and caution is required if such drugs are administered with both calcium chloride and other calcium-containing preparations.

4.6 Pregnancy And Lactation

Calcium chloride has no known effects on the foetus or infant, but as with all drugs it should not be administered during pregnancy or breast feeding unless considered essential.

4.7 Effects On Ability To Drive And Use Machines

None stated.

4.8 Undesirable Effects

Rapid intravenous injection may cause vasodilation, decreased blood pressure, bradycardia and arrhythmias.

The patient may complain of tingling sensations, a chalky 'calcium' taste and a sense of oppression or 'heat wave'.

Irritation can occur after intravenous injection. Extravasation can cause burning, necrosis and sloughing of tissue, cellulitis and soft tissue calcification.

Hypertension

Venous thrombosis

Hypercalcemia

4.9 Overdose

Excessive administration of calcium salts leads to hypercalcaemia. Too rapid injection of calcium salts may also lead to many of the symptoms of hypercalcaemia as well as chalky taste, hot flushes and peripheral vasodilation. Treatment of hypercalcaemia is by the administration of sodium chloride by intravenous infusion. Cardiac arrhythmia and cardiac arrest may occur.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

ATC code:A12 A07

Calcium is an essential electrolyte involved in the function of nervous, muscular and skeletal systems, cell membrane and capillary permeability. The cation is also an important activator in many enzymatic reactions and plays a regulatory role in the release and storage of neurotransmitters and hormones.

5.2 Pharmacokinetic Properties

Intravenously administered calcium will be absorbed directly into the blood system. Serum calcium levels will increase immediately and may return to normal values in thirty minutes to two hours depending on the rate of renal clearance.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Sodium hydroxide

Hydrochloric acid

Water for injections

6.2 Incompatibilities

Calcium salts are incompatible with oxidising agents, citrates, soluble carbonates, bicarbonates, phosphates, tartrates and sulphates.

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

Store below 25°C.

6.5 Nature And Contents Of Container

10ml neutral Type 1 glass ampoules in packs of 10.

6.6 Special Precautions For Disposal And Other Handling

None stated.

7. Marketing Authorisation Holder

UCB Pharma Limited

208 Bath Road

Slough

Berkshire

SL1 3 WE

UK

8. Marketing Authorisation Number(S)

PL 00039/5888R

9. Date Of First Authorisation/Renewal Of The Authorisation

18 February 1993, 17 February 2003

10. Date Of Revision Of The Text

January 2010

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Liposyn III

Dosage Form: injection, emulsion
Liposyn® III

INTRAVENOUS FAT EMULSION

Rx Only

Liposyn III Description

Liposyn III (Intravenous Fat Emulsion) is a sterile, nonpyrogenic fat emulsion for intravenous administration. It is supplied in both a 10% and 20% concentration.

Liposyn III 10% contains 10% soybean oil, up to 1.2% egg phosphatides added as an emulsifier and 2.5% glycerin in water for injection. Sodium hydroxide has been added for pH adjustment. pH 8.3 (6.0 to 9.0). Liposyn III 10% has an osmolarity of 284 mOsmol/L (approx.) and a specific gravity of 0.995. The total caloric value of Liposyn III 10% including fat, phospholipid and glycerol is 1.1 kcal/mL. Of this total, approximately 0.5 kcal/mL is supplied by linoleic acid.

Liposyn III 20% contains 20% soybean oil, 1.2% egg phosphatides and 2.5% glycerin in water for injection. Sodium hydroxide has been added for pH adjustment. pH 8.3 (6.0 to 9.0). Liposyn III 20% has an osmolarity of 292 mOsmol/L (approx.) and a specific gravity of 0.988. The total caloric value of Liposyn III 20% including fat, phospholipid and glycerol is 2.0 kcal/mL. Of this total, approximately 1.0 kcal/mL is supplied by linoleic acid.

Both Liposyn III 10% and Liposyn III 20% contain emulsified fat particles of approximately 0.4 micron in diameter, similar to naturally occurring chylomicrons.

Soybean Oil, USP is a mixture of neutral triglycerides with the following structure:

,

and

are saturated and unsaturated fatty acid residues. The major component fatty acids are approximately 54.5% linoleic, 22.4% oleic, 10.5% palmitic, 4.2% stearic, and 8.3% linolenic acid. These fatty acids have the following chemical and structural formulas: 

Linoleic acid

C18H32O2

Oleic acid

C18H34O2

Palmitic acid

C16H32O2

Stearic acid

C18H36O2

Linolenic acid

C18H30O2

Egg phosphatides, purified, are primarily a mixture of naturally occurring phospholipids which are isolated from the egg yolk. These phospholipids have the following general structure:

are the same saturated and unsaturated fatty acid residues that abound in neutral fats. R3 is primarily either the choline [HOCH2CH2N(CH3)3OH] ester or ethanolamine (HOCH2CH2NH2) ester of phosphoric acid (H3PO4).

Glycerin, USP is chemically designated C3H803 and is a clear, colorless, hygroscopic syrupy liquid. It has the following structural formula:

Liposyn III - Clinical Pharmacology

Liposyn III (intravenous fat emulsion) provides the patient requiring parenteral nutrition with a source of calories and the essential fatty acids normally obtained from a nutritionally complete oral diet. The supplemental polyunsaturated fat prevents biochemical changes of essential fatty acid deficiency (EFAD) and prevents and reverses EFAD clinical manifestations (e.g., scaliness of skin, growth retardation, poor wound healing and sparse hair growth).

The infused fat particles are cleared from the bloodstream in a manner thought to be similar to the clearing of chylomicrons. Following infusion, there is a transient increase in plasma triglycerides. The triglycerides are hydrolyzed to free fatty acids and glycerol by the enzyme, lipoprotein lipase. The free fatty acids either enter the tissues (where they may be oxidized or resynthesized into triglycerides and stored) or circulate in the plasma, bound to albumin. In the liver, circulating free fatty acids are oxidized or converted to very low density lipoproteins that re-enter the bloodstream.

Phosphatides are the hydrophobic components of membranes and provide electrically insulated layers. They are involved in the formation of membrane structures. Choline prevents the deposition of fat in the liver.

Glycerol is metabolized to carbon dioxide and glycogen or is used in the synthesis of body fats.

Indications and Usage for Liposyn III

Liposyn III (intravenous fat emulsion) is indicated as a source of calories for patients requiring parenteral nutrition. Where such nutrition is required for extended periods of time (more than 5 days), Liposyn III is also indicated as a source of essential fatty acids to prevent or reverse biochemical changes in fatty acid composition of plasma lipids (elevated triene/tetraene ratio) and the clinical manifestations of EFAD.

Contraindications

The administration of Liposyn III (intravenous fat emulsion) is contraindicated in patients demonstrating disturbances in normal fat metabolism such as pathologic hyperlipemia, lipoid nephrosis or acute pancreatitis if accompanied by hyperlipemia.

With the exception of heparin at 1 to 2 units/mL of fat emulsion, additives to the Liposyn III bottle are contraindicated.

Partly used containers must not be stored for later use. Filters must not be used with Liposyn III. Do not use any bottle in which there appears to be an oiling out of the emulsion.

Warnings

Deaths in preterm infants after infusion of intravenous fat emulsions have been reported in the medical literature.1,2 Autopsy findings included intravascular fat accumulation in the lungs. Treatment of premature and low birth weight infants with intravenous fat emulsion must be based upon careful benefit-risk assessment. Strict adherence to the recommended total daily dose is mandatory; hourly infusion rate should be as slow as possible in each case and should not in any case exceed 1 g/kg in four hours. Premature and small for gestational age infants have poor clearance of intravenous fat emulsion and increased free fatty acid plasma levels following fat emulsion infusion; therefore, serious consideration must be given to administration of less than the maximum recommended doses in these patients in order to decrease the likelihood of intravenous fat overload. The infant’s ability to eliminate infused fat from the circulation must be carefully monitored (such as triglyceride and/or plasma free fatty acid levels). The lipemia must clear between daily infusions.

Caution should be exercised in administering Liposyn III (intravenous fat emulsion) to patients with severe liver damage, pulmonary disease, anemia or blood coagulation disorders or when there is danger of fat embolism. The too rapid administration of Liposyn III can cause fluid and/or fat overloading resulting in dilution of serum electrolyte concentrations, over-hydration, congested states, pulmonary edema, impaired pulmonary diffusion capacity or metabolic acidosis.

WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.

Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

Precautions

Because free fatty acids displace bilirubin bound to albumin, the use of lipid infusions in jaundiced or premature infants should be undertaken with caution.

During Liposyn III (intravenous fat emulsion) administration, the patient’s hemogram, blood coagulation, liver function, platelet count and plasma lipid profile must be closely monitored. The lipemia must clear between daily infusions. Liposyn III should be discontinued should a significant abnormality in any one of these parameters be attributed to the infusion.

Pregnancy Category C.

Animal reproduction studies have not been conducted with Liposyn III. It is also not known whether Liposyn III can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Liposyn III should be given to a pregnant woman only if clearly needed.

Liposyn III is supplied in single-dose containers. Partially used containers must be discarded and should not be stored or resterilized for later use. Do not administer the contents of any container in which the emulsion appears to be oiling out.

This product contains no more than 25 mcg/L of aluminum.

Adverse Reactions

Sepsis due to contamination of administration equipment and thrombophlebitis due to vein irritation from concurrently administered hypertonic solutions have been encountered. These are attributable to I.V. therapy in general or to the type of infusion administered.

Adverse reactions directly related to fat emulsions are of two types: (1) immediate (acute) and (2) long term (chronic). In studies of lipid products in general, the following immediate reactions have been noted: Allergic reactions, hyperlipemia, dyspnea, cyanosis, flushing, dizziness, headache, sleepiness, nausea, vomiting, hyperthermia, sweating, chest and back pain, thrombocytopenia (rarely in neonates), hypercoagulability and transient increases in liver enzymes.

The following reactions have been noted with long-term therapy with lipid infusions in general: Hepatomegaly, jaundice due to central lobular cholestasis, splenomegaly, thrombocytopenia, leucopenia, transient increases in liver function tests, overloading syndrome and the deposition of brown pigment (“fat pigment”) in the reticuloendothelial tissue of the liver. The significance of this last occurrence and its cause are unknown.

Overdosage

In the event of fat overload during therapy, stop the infusion of Liposyn III until visual inspection of the plasma, determination of triglyceride concentrations, or measurement of plasma light-scattering activity by nephelometry indicates the lipid has cleared. Re-evaluate the patient and institute appropriate corrective measures. See WARNINGS and PRECAUTIONS.

Liposyn III Dosage and Administration

Liposyn III (intravenous fat emulsion) should be administered as part of an intravenous total nutrition program via peripheral vein or central venous catheter.

Adult Patients

Liposyn III can provide up to 60% of daily calories at a dose not to exceed 3 g/kg of body weight per day. The other 40% should be provided by carbohydrate and amino acids.

For the prevention of essential fatty acid deficiency, the recommended daily requirement is approximately 4% of the caloric intake as linoleate. In most adult patients, this can be supplied as 500 mL of Liposyn III 10% or 250 mL of Liposyn III 20% administered three times weekly.

The initial infusion rate for the first 15 minutes should be 1.0 mL/minute for Liposyn III 10% and 0.5 mL/minute for Liposyn III 20%. If no adverse effects are observed during this initial infusion, the rate can be increased to allow no more than 500 mL of Liposyn III 10% or 250 mL of Liposyn III 20% to be given over a period of four to six hours.

Pediatric Patients

Liposyn III can provide up to 60% of daily calories at a dose not to exceed 4 g/kg of body weight per day. The other 40% should be provided by carbohydrate and amino acids.

For the prevention of essential fatty acid deficiency, the recommended daily requirement is approximately 4% of the caloric intake as linoleate. The daily dosage of Liposyn III ranges from 7.5 mL to 15 mL per kilogram for the 10% emulsion and 3.8 mL to 7.5 mL per kilogram for the 20% emulsion, depending upon the size and maturity of the patient.

The infusion should be started at a rate of 0.1 mL/minute for the first 15 minutes. If no adverse effects are observed during this initial infusion, the rate can be increased to allow no more than 100 mL of Liposyn III 10% or 50 mL of Liposyn III 20% per hour.

Administration

See CONTRAINDICATIONS regarding mixing this emulsion with other I.V. fluids or additives.

Liposyn III can be infused into the same central or peripheral vein as the carbohydrate/amino acid solutions by means of a short Y-connector near the infusion site. This allows for mixing of the solutions immediately before entering the vein or for alternation of each solution. Flow rates of each solution should be controlled separately by infusion pumps, if these are used. Fat emulsion may also be infused through a separate peripheral site. If desired, heparin may be added to Liposyn III at a concentration of 1 to 2 units per mL prior to administration. Conventional administration sets contain polyvinyl chloride (PVC) components that have DEHP (diethylhexyl phthalate) as a plasticizer. Fat-containing fluids such as Liposyn extract DEHP from this PVC component, and it may be advisable to consider infusion of Liposyn III through a non-DEHP administration set. Filters should not be used for administration of the emulsion. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

How is Liposyn III Supplied

Liposyn III (intravenous fat emulsion) 10% and 20% is a white to slightly off-white emulsion with no evidence of oiling out of the emulsion.

Liposyn III 10% (List No. 9790) is supplied in 200, 250 and 500 mL single-dose containers. Liposyn III 20% (List No. 9791) is supplied in 200, 250 and 500 mL single-dose containers.

Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing.

References

1.    Levene M, Wigglesworth J, Desai R. Pulmonary fat accumulation after Intralipid infusion in the preterm infant.

        Lancet II: 815-818, (Oct. 18), 1980.

2.    Dahms B, Halpin T. Pulmonary arterial lipid deposit in newborn infants receiving intravenous lipid infusion.

        J. Pediatrics: 97:800-805, (Nov.), 1980.

Revised: September, 2005

©Hospira 2005                            EN - 1013                            Printed in USA

Hospira, Inc., Lake Forest, IL 60045 USA

RL-2263

RL-2264

LIPOSYN III 
soybean oil, egg phospholipids, and glycerin  injection, emulsion Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0409-9790 Route of Administration INTRAVENOUS DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SOYBEAN OIL (SOYBEAN OIL) SOYBEAN OIL 10 g  in 100 mL EGG PHOSPHOLIPIDS (EGG PHOSPHOLIPIDS) EGG PHOSPHOLIPIDS 1.2 g  in 100 mL GLYCERIN (GLYCERIN) GLYCERIN 2.5 g  in 100 mL Inactive Ingredients Ingredient Name Strength WATER   SODIUM HYDROXIDE   Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 0409-9790-02 12 BOTTLE In 1 CASE contains a BOTTLE, GLASS 1 250 mL In 1 BOTTLE, GLASS This package is contained within the CASE (0409-9790-02) 2 0409-9790-03 12 BOTTLE In 1 CASE contains a BOTTLE, GLASS 2 500 mL In 1 BOTTLE, GLASS This package is contained within the CASE (0409-9790-03)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA018969 02/11/2011
LIPOSYN III 
soybean oil, egg phospholipids, and glycerin  injection, emulsion Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0409-9791 Route of Administration INTRAVENOUS DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SOYBEAN OIL (SOYBEAN OIL) SOYBEAN OIL 20 g  in 100 mL EGG PHOSPHOLIPIDS (EGG PHOSPHOLIPIDS) EGG PHOSPHOLIPIDS 1.2 g  in 100 mL GLYCERIN (GLYCERIN) GLYCERIN 2.5 g  in 100 mL Inactive Ingredients Ingredient Name Strength WATER   SODIUM HYDROXIDE   Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 0409-9791-02 12 BOTTLE In 1 CASE contains a BOTTLE, GLASS 1 250 mL In 1 BOTTLE, GLASS This package is contained within the CASE (0409-9791-02) 2 0409-9791-03 12 BOTTLE In 1 CASE contains a BOTTLE, GLASS 2 500 mL In 1 BOTTLE, GLASS This package is contained within the CASE (0409-9791-03)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA018970 02/11/2011
Labeler - Hospira, Inc. (141588017) Revised: 12/2009Hospira, Inc. More Liposyn III resources Liposyn III Drug Interactions Liposyn III Support Group 0 Reviews · Be the first to review/rate this drug

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D-GAM, Solution for Injection 1,500 and 2,500iu vials

1. Name Of The Medicinal Product

D-GAM ®, Human Anti-D Immunoglobulin, 1,500 and 2,500 IU, solution for injection.

2. Qualitative And Quantitative Composition

Each vial contains either 1500 IU or 2500 IU human Anti-D immunoglobulin

One mL contains 1250 IU/mL human Anti-D immunoglobulin.

*100 micrograms of human anti-D immunoglobulin correspond to 500 international units (IU).

Human protein content 20 - 180 g/L of which at least 95% is IgG.

For excipients see 6.1.

3. Pharmaceutical Form

A solution for injection.

4. Clinical Particulars 4.1 Therapeutic Indications

Prevention of RhD immunisation in RhD negative women:

i. Pregnancy/delivery of a RhD positive baby.

ii. Abortion/threatened abortion, ectopic pregnancy or hydatidiform mole.

iii. After ante-partum haemorrhage (APH), amniocentesis, chorionic biopsy or obstetric manipulative procedure e.g. external version, or abdominal trauma, which may cause transplacental haemorrhage (TPH).

Treatment of RhD negative patients after transfusions of RhD positive blood or other products containing RhD positive red blood cells (e.g. platelets).

4.2 Posology And Method Of Administration

Posology

a) Post-Natal Dosage:

The recommended dose is 500 IU.

For postnatal use, the product should be administered as soon as possible within 72 hours of delivery.

If a large fetomaternal haemorrhage is suspected, its extent should be determined by a suitable method and additional doses of anti-D should be administered as indicated.

b) Ante-Natal Prophylaxis:

A single dose of 1,500 IU at 28 weeks of gestation, or

500 IU given at both 28 and 34 weeks of gestation.

c) Following a Potentially Sensitising Event During Pregnancy:

D-GAM ® should be administered as soon as possible and no later than 72 hours after the event.

Up to 20 weeks gestation: recommended dose is 250 IU per incident.

After 20 weeks gestation: recommended dose is 500 IU per incident. A test for the size of the FMH should be performed when anti-D is given after 20 weeks and additional doses of anti-D should be administered as indicated.

d) Prevention of Immunisation in RhD Negative Patients Given Blood Components Containing RhD Positive Cells:

Recommended doses: 125 IU per mL of transfused RhD positive red cells; 250 IU per three adult doses of platelets.

Method of administration

For intramuscular use (preferably into the deltoid muscle).

D-GAM ® vials are for single use only.

In the case of haemorrhagic disorders, where intramuscular injections are contra-indicated, Anti-D immunoglobulin may be administered subcutaneously. Careful manual pressure with a compress should be applied to the site after injection.

If large total doses (>5 mL) are required, it is advisable to administer them in divided doses at different sites.

4.3 Contraindications

Hypersensitivity to any of the components.

4.4 Special Warnings And Precautions For Use

Do not administer this product intravenously (risk of shock).

In the case of post-partum use, the product is intended for maternal administration. It should not be given to the newborn infant.

The product is not intended for use in RhD positive individuals.

Patients should be observed for at least 20 minutes after administration.

If symptoms of allergic or anaphylactic type reactions occur, immediate discontinuation of the administration is required.

True hypersensitivity reactions are rare but allergic type responses to Anti-D immunoglobulin may occur. Patients should be informed of the early signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis. The treatment required depends on the nature and severity of the side effect. In case of shock, the current medical standards for shock treatment should be observed.

D-GAM ® contains a small quantity of IgA. Although anti-D immunoglobulin has been used successfully to treat selected IgA deficient individuals, the attending physician must weigh the benefit against the potential risks of hypersensitivity reactions. Individuals deficient in IgA have a potential for development of IgA antibodies and anaphylactic reactions after administration of blood components containing IgA.

Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses. Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens.

The viral removal/inactivation procedures may be of limited value against non-enveloped viruses such as hepatitis A virus or parvovirus B19.

In the interest of patients, it is recommended that, whenever possible, every time that D-GAM ® is administered to them, the name and batch number of the product is registered.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Active immunisation with live virus vaccines (e.g. measles, mumps or rubella) should be postponed until 3 months after the administration of Anti-D immunoglobulin, as the efficacy of the live virus vaccine may be impaired. If Anti-D immunoglobulin needs to be administered within 2-4 weeks of a live virus vaccination, then the efficacy of such a vaccination may be impaired.

After injection of immunoglobulin, the transitory rise of the various passively transferred antibodies in the patient's blood may result in misleading positive results in serological testing.

The results of blood typing and antibody testing, including the Coombs' or antiglobulin test, are significantly affected by the administration of anti-D immunoglobulin.

4.6 Pregnancy And Lactation

This medicinal product is used in pregnancy.

4.7 Effects On Ability To Drive And Use Machines

No effects on ability to drive and use machines have been observed.

4.8 Undesirable Effects

Local pain and tenderness can be observed at the injection site; this can be prevented by dividing larger doses over several injection sites.

The following side effects are known to be associated with Anti-D (the incidence has not been quantified): Occasionally fever, malaise, headache, cutaneous reactions and chills occur. In rare cases: nausea, vomiting, hypotension, tachycardia and allergic or anaphylactic type reactions, including dyspnoea and shock, are reported, even when the patient has shown no hypersensitivity to previous administration.

For information on viral safety see 4.4.

4.9 Overdose

No data are available on overdosage. RhD negative patients who are given RhD positive blood or other products containing RhD positive red blood cells and receive anti-D immunoglobulin should be monitored clinically and by biological parameters, because of the risk of haemolytic reaction.

In other RhD negative individuals, overdosage should not lead to more frequent or more severe undesirable effects than the normal dose.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: immune sera and immunoglobulins: Anti-D (Rh) immunoglobulin. ATC code: J06B B01.

Anti-D immunoglobulin contains specific antibodies (IgG) against the RhD antigen of human erythrocytes.

5.2 Pharmacokinetic Properties

Measurable levels of antibodies are obtained approximately 8 hours after intramuscular injection. Peak serum levels are usually achieved 2 to 4 days later.

The half-life in the circulation of individuals with normal IgG levels is 3 to 5 weeks.

IgG and IgG-complexes are broken down in cells of the reticuloendothelial system.

5.3 Preclinical Safety Data

D-GAM ® is a preparation of human plasma proteins, so safety testing in animals is not particularly relevant to the safety of use in man. Acute toxicity studies in rat and mouse showed species specific reactions, which bear no relevance to administration in humans.

Repeated dose safety testing is impracticable due to the induction of and interference with antibodies to human protein. Clinical experience provides no sign of tumourigenic and mutagenic effects.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Sodium chloride

Glycine

Sodium acetate trihydrate

Sodium hydroxide

6.2 Incompatibilities

This medicinal product must not be mixed with other medicinal products.

6.3 Shelf Life

Stored at 2° - 8°C:

2 years.

Stored at 25°C:

1 week.

6.4 Special Precautions For Storage

D-GAM ® should be stored in the original container at 2°C to 8°C. Storage for up to one week at ambient temperatures (25°C) in the original container is not detrimental. DO NOT FREEZE.

The condition of date-expired, or incorrectly stored product cannot be guaranteed. Such product may be unsafe, and should not be used.

6.5 Nature And Contents Of Container

Neutral borosilicate glass vial (Type I Ph.Eur.) with overseal consisting of a halobutyl rubber wad (Type I Ph.Eur.), clear lacquered aluminium skirt and flip-off polypropylene cap.

6.6 Special Precautions For Disposal And Other Handling

The product should be brought to room or body temperature before use.

The solution should be clear or slightly opalescent. Do not use solutions which are cloudy or have deposits.

Any unused product or waste material should be disposed of in accordance with local requirements.

7. Marketing Authorisation Holder

Bio Products Laboratory

Dagger Lane

Elstree

Hertfordshire

WD6 3BX

United Kingdom.

8. Marketing Authorisation Number(S)

PL 08801/0049 - 1,500 IU and 2,500 IU dose sizes.

9. Date Of First Authorisation/Renewal Of The Authorisation

31 July 2000

10. Date Of Revision Of The Text

11th August 2011

Version Code: SDS5C

POM

 

 

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Poractant Alfa

Class: Pulmonary Surfactants
VA Class: RE900
CAS Number: 129069-19-8
Brands: Curosurf

Introduction

Exogenous natural pulmonary surfactant preparation; porcine lung extract containing mostly phospholipids.1 3

Uses for Poractant Alfa Respiratory Distress Syndrome (RDS)

Treatment (rescue) of RDS (hyaline membrane disease) in premature neonates (designated an orphan drug by FDA for this use).1 2 6 8

Prevention† of RDS in infants at high risk for RDS.3 7 8

Poractant Alfa Dosage and Administration General

Observe clinical status and monitor systemic oxygenation frequently; decrease inspired oxygen concentrations and ventilator pressures gradually to prevent hyperoxia.1 2

Following completion of dosing procedure, resume usual ventilator management and clinical care.1 Do not suction airways for 1 hour after dosing unless substantial obstruction occurs.1 (See Experience of Supervising Clinician under Cautions.)

Administration Intratracheal Administration

Administer only by intratracheal instillation using specialized techniques.1 Consult manufacturer’s labeling or specialized references for guidelines on administration techniques.1 2

Allow drug to reach room temperature before administration.1 Gently invert vial to obtain a uniform suspension; do not shake.1

Contains no preservatives; discard unused portion.1

Dosage

Available as poractant alfa; dosage expressed in terms of phospholipids.1 4 5

Each mL of the commercially available formulation contains 80 mg of phospholipids (including 54 mg of phosphatidylcholine, of which 30.5 mg is dipalmitoyl phosphatidylcholine) and 1 mg of surfactant proteins (SP-B, SP-C).1 2 8

Pediatric Patients Treatment of RDS Intratracheal

Premature neonates: 2.5 mL/kg (200 mg/kg) of birthweight.1

Administer up to 2 repeat doses (1.25 mL/kg of birth weight), given at 12-hour intervals, if neonate remains intubated and respiratory manifestations of RDS persist or worsen.1

Prevention of RDS† Intratracheal

100 or 200 mg/kg, given as a single dose within 10 minutes of birth.3 7

Prescribing Limits Pediatric Patients Treatment of RDS Intratracheal

Premature neonates: Total dosage (initial and repeat doses) should not exceed 5 mL/kg.1 Safety and efficacy not established for administration of >3 doses (1 initial and 2 repeat doses), administration more frequently than every 12 hours, and initiation of therapy >15 hours after diagnosis of RDS.1

Cautions for Poractant Alfa Contraindications

No known contraindications.1

Warnings/Precautions Warnings Experience of Supervising Clinician

Use only by clinicians experienced in resuscitation, stabilization, and general care of premature neonates.1

Respiratory Effects

Therapy can rapidly affect oxygenation and lung compliance.1 Perform frequent clinical and laboratory assessments; modify oxygen and ventilatory support in response to respiratory changes.1 2

Transient episodes of decreased oxygen saturation reported.1 If this occurs, discontinue administration and initiate appropriate measures to alleviate the condition; following stabilization, resume therapy and monitor appropriately.1

Cardiovascular Effects

Transient episodes of bradycardia and hypotension reported.1 If these occur, discontinue administration and initiate appropriate measures to alleviate the condition; following stabilization, resume therapy and monitor appropriately.1

Endotracheal Tube Complications

Transient endotracheal tube blockage, reflux of surfactant into endotracheal tube, and airway obstruction reported.1 If these occur, discontinue administration and initiate appropriate measures to alleviate the condition; following stabilization, resume therapy and monitor appropriately.1

General Precautions Concurrent Illness

Correction of acidosis, hypotension, anemia, hypoglycemia, and hypothermia recommended prior to administration.1

Complications of Prematurity

Therapy expected to reduce severity of RDS but will not eliminate morbidity and mortality associated with other complications of prematurity (e.g., pneumonia, septicemia, intracranial hemorrhage, patent ductus arteriosus).1

Use with Investigational Treatments for RDS

Safety and efficacy in conjunction with investigational therapies for RDS (e.g., high-frequency ventilation) not established.1

Specific Populations Pregnancy

Not intended for use in adults.1

Lactation

Not intended for use in adults.1

Common Adverse Effects

Transient bradycardia, hypotension, endotracheal tube blockage, decreased oxygen saturation.1

Interactions for Poractant Alfa

No drug interactions reported.1

Poractant Alfa Pharmacokinetics

No pharmacokinetic studies in humans.1

Absorption Onset

Marked improvements in oxygenation occur within minutes of administration.1

Stability Storage Intratracheal Suspension

2–8° C.1 Protect from light.1

Prior to use, warm to room temperature for up to 24 hours.1

May return unopened, unused vials to refrigerator within 24 hours of warming.1 Do not warm and return to refrigeration more than once.1

ActionsActions

Natural porcine lung extract containing mostly phospholipids and small amounts of neutral lipids, fatty acids, and surfactant-associated proteins (SP-B, SP-C).1 3

Endogenous pulmonary surfactant reduces alveolar surface tension and increases alveolar stability.1

Poractant compensates for surfactant deficiency in premature neonates.1 Increases alveolar stability and pulmonary compliance, decreases pulmonary edema and work required for breathing, and facilitates uniform alveolar recruitment on inspiration.1 3

Advice to Patients

Advise patient’s parent(s) or guardian that other complications of prematurity (e.g., pneumonia, septicemia, intracranial hemorrhage, patent ductus arteriosus) will not be eliminated by poractant therapy.1

Importance of informing parent(s) or guardian of other important precautionary information. (See Cautions.)1

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Poractant Alfa

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Intratracheal

Suspension

1.5 mL (120 mg phospholipids)

Curosurf

Dey

3 mL (240 mg phospholipids)

Curosurf

Dey

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions September 2005. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

1. Dey. Curosurf (poractant alfa) intratracheal suspension prescribing information. Napa, CA; 2000 Feb.

2. Anon. Med Lett Drugs Ther. 42; 2000;27-8.

3. Wiseman LR, Bryson HM. Porcine-derived lung surfactant: a review of the therapeutic efficacy and clinical tolerability of a natural surfactant preparation (Curosurf) in neonatal respiratory distress syndrome. Drugs. 1994; 48:386-403. [PubMed 7527760]

4. Collaborative European Multicenter Study Group. Surfactant replacement therapy for severe neonatal respiratory distress syndrome: an international randomized clinical trial. Pediatrics. 1988; 82:683-91. [IDIS 247745] [PubMed 2903480]

5. Speer CP, Robertson B, Curstedt T et al. Randomized European multicenter trial of surfactant replacement therapy for severe neonatal respiratory distress syndrome: single versus multiple doses of Curosurf. Pediatrics. 1992; 89:13-20. [IDIS 290105] [PubMed 1727997]

6. Food and Drug Administration. Orphan designations pursuant to Section 526 of the Federal Food and Cosmetic Act as amended by the Orphan Drug Act (P.L. 97-414). Rockville, MD; [December 18, 2000]. From FDA web site ().

7. Egberts J, Brand R, Walti H et al. Mortality, severe respiratory distress syndrome, and chronic lung disease of the newborn are reduced more after prophylactic than after therapeutic administration of the surfactant Curosurf. Pediatrics. 1997; 100: E4. [IDIS 427502] [PubMed 9200378]

8. Dey, Napa, CA: Personal communication.

More Poractant Alfa resources Poractant Alfa Use in Pregnancy & Breastfeeding Poractant Alfa Support Group 0 Reviews for Poractant Alfa - Add your own review/rating Curosurf Prescribing Information (FDA) Compare Poractant Alfa with other medications Respiratory Distress Syndrome

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Prevident 5000 Sensitive

sodium fluoride and potassium nitrate gel
Dosage Form: gel, dentifrice
Colgate®
PreviDent®5000 ppm

SENSITIVE

Rx ONLY

1.1% Sodium Fluoride, 5% Potassium Nitrate

Prescription Strength Toothpaste for Sensitive Teeth

Prevident 5000 Sensitive Description

Self-topical neutral fluoride toothpaste containing 1.1% (w/w) sodium fluoride and 5% potassium nitrate.

Active Ingredients

Sodium fluoride 1.1% (w/w), Potassium nitrate 5%

Inactive Ingredients

water, hydrated silica, sorbitol, PEG-12, carrageenan, sodium lauryl sulfate, flavor, poloxamer 407, cocamidopropyl betaine, sodium saccharin, mica, sodium hydroxide, titanium dioxide, D&C yellow no. 10, FD&C blue no. 1

Prevident 5000 Sensitive - Clinical Pharmacology

Frequent topical applications to the teeth with preparations having a relatively high fluoride content increase tooth resistance to acid dissolution and enhance penetration of the fluoride ion into tooth enamel.

Indications and Usage for Prevident 5000 Sensitive

A dental caries preventive and sensitive teeth toothpaste; for twice daily self-applied topical use, followed by rinsing. Helps reduce the painful sensitivity of the teeth to cold, heat, acids, sweets or contact in adult patients and children 12 years of age and older. It is well established that 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently with mouthpiece applicators. 1-4 PreviDent® 5000 Sensitive brand of 1.1% sodium fluoride toothpaste with 5% potassium nitrate in a squeeze bottle is easily applied onto a toothbrush. This prescription toothpaste should be used twice daily in place of your regular toothpaste unless otherwise instructed by your dental professional. May be used in areas where drinking water is fluoridated since topical fluoride cannot produce fluorosis. (See WARNINGS for exception.)

Contraindications

Do not use in pediatric patients under age 12 years unless recommended by a dentist or physician.

Warnings

Not for systemic treatment - DO NOT SWALLOW. Keep out of reach of infants and children. Children under 12 years of age, consult a dentist or physician.

Note: Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. See your dentist if the problem persists or worsens. Do not use this product longer than 4 weeks unless recommended by a dentist or physician.

Precautions General

Not for systemic treatment. DO NOT SWALLOW.

Carcinogenesis, Mutagenesis, Impairment of Fertility

In a study conducted in rodents, no carcinogenesis was found in male and female mice and female rats treated with fluoride at dose levels ranging from 4.1 to 9.1 mg/kg of body weight. Equivocal evidence of carcinogenesis was reported in male rats treated with 2.5 and 4.1 mg/kg of body weight. In a second study, no carcinogenesis was observed in rats, males or females, treated with fluoride up to 11.3 mg/kg of body weight. Epidemiological data provide no credible evidence for an association between fluoride, either naturally occurring or added to drinking water, and risk of human cancer.

Fluoride ion is not mutagenic in standard bacterial systems. It has been shown that fluoride ion has potential to induce chromosome aberrations in cultured human and rodent cells at doses much higher than those to which humans are exposed. In vivo data are conflicting. Some studies report chromosome damage in rodents, while other studies using similar protocols report negative results.

Potential adverse reproductive effects of fluoride exposure in humans has not been adequately evaluated. Adverse effects on reproduction were reported for rats, mice, fox, and cattle exposed to 100 ppm or greater concentrations of fluoride in their diet or drinking water. Other studies conducted in rats demonstrated that lower concentrations of fluoride (5 mg/kg of body weight) did not result in impaired fertility and reproductive capabilities.

Pregnancy Teratogenic Effects Pregnancy Category B

It has been shown that fluoride crosses the placenta of rats, but only 0.01% of the amount administered is incorporated in fetal tissue. Animal studies (rats, mice, rabbits) have shown that fluoride is not a teratogen. Maternal exposure to 12.2 mg fluoride/kg of body weight (rats) or 13.1 mg/kg of body weight (rabbits) did not affect the litter size or fetal weight and did not increase the frequency of skeletal or visceral malformations. There are no adequate and well-controlled studies in pregnant women. However, epidemiological studies conducted in areas with high levels of naturally fluoridated water showed no increase in birth defects. Heavy exposure to fluoride during in utero development may result in skeletal fluorosis which becomes evident in childhood.

Nursing Mothers

It is not known if fluoride is excreted in human milk. However, many drugs are excreted in milk, and caution should be exercised when products containing fluoride are administered to a nursing woman. Reduced milk production was reported in farm-raised fox when the animals were fed a diet containing a high concentration of fluoride (98-137 mg/kg of body weight). No adverse effects on parturition, lactation, or offspring were seen in rats administered fluoride up to 5 mg/kg of body weight.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 12 years have not been established. Please refer to the CONTRAINDICATIONS and WARNINGS sections.

Geriatric Use

Of the total number of subjects in clinical studies of 1.1% (w/v) sodium fluoride, 15 percent were 65 and over, while 1 percent were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.5

Adverse Reactions

Allergic reactions and other idiosyncrasies have been rarely reported.

Overdosage

Accidental ingestion of large amounts of fluoride may result in acute burning in the mouth and sore tongue. Nausea, vomiting, and diarrhea may occur soon after ingestion (within 30 minutes) and are accompanied by salivation, hematemesis, and epigastric cramping abdominal pain. These symptoms may persist for 24 hours. If less than 5 mg fluoride/kg body weight (i.e., less than 2.3 mg fluoride/lb body weight) have been ingested, give calcium (e.g., milk) orally to relieve gastrointestinal symptoms and observe for a few hours. If more than 5 mg fluoride/kg body weight (i.e., more than 2.3 mg fluoride/lb body weight) have been ingested, induce vomiting, give orally soluble calcium (e.g., milk, 5% calcium gluconate or calcium lactate solution) and immediately seek medical assistance. For accidental ingestion of more than 15 mg fluoride/kg of body weight (i.e., more than 6.9 mg fluoride/lb body weight), induce vomiting and admit immediately to a hospital facility.

A treatment dose (a thin ribbon) of PreviDent® 5000 Sensitive contains approximately 2.5 mg fluoride. A 3.4 FL OZ (100 mL) bottle contains approximately 575 mg fluoride.

Prevident 5000 Sensitive Dosage and Administration

Follow these instructions unless otherwise instructed by your dental professional:

Adults and children 12 years of age and older: Apply at least 1 inch strip of PreviDent® 5000 Sensitive onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute, expectorate, and rinse mouth thoroughly. Use twice a day (morning and evening) or as recommended by a dentist or physician. Make sure to brush all sensitive areas of the teeth. Children under 12 years of age: Consult a dentist or physician. How is Prevident 5000 Sensitive Supplied

3.4 FL OZ (100 mL) in plastic bottles. Mild Mint: NDC 0126-0070-61

STORAGE

Store at Controlled Room Temperature, 68-77°F (20-25°C)

REFERENCES American Dental Association, Accepted Dental Therapeutics Ed. 40 (Chicago, 1984): 405-407. H.R. Englander et al., JADA 75 (1967): 638-644. H.R. Englander et al., JADA 78 (1969): 783-787. H.R. Englander et al., JADA 83 (1971): 354-358. Data on file, Colgate Oral Pharmaceuticals.

Questions? Comments? Please Call 1-800-962-2345
www.colgateprofessional.com

PRINCIPAL DISPLAY PANEL 100 mL Bottle

NDC 0126-0070-61

Colgate®

PreviDent®
5000ppm

SENSITIVE
1.1% Sodium Fluoride
5% Potassium Nitrate

PRESCRIPTION STRENGTH
TOOTHPASTE FOR SENSITIVE TEETH

MILD MINT

3.4 FL OZ (100 mL)

Rx ONLY

P10000587

PREVIDENT  5000 SENSITIVE
sodium fluoride  gel, dentifrice Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0126-0070 Route of Administration DENTAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium fluoride (fluoride ion) Sodium fluoride 12.7 mg  in 1 mL Potassium nitrate (Potassium cation) Potassium nitrate 57.5 mg  in 1 mL Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color GREEN Score      Shape Size Flavor PEPPERMINT Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 0126-0070-61 100 mL In 1 BOTTLE None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 07/06/2009
Labeler - Colgate-Palmolive Company (055002195) Revised: 07/2009Colgate-Palmolive Company More Prevident 5000 Sensitive resources Prevident 5000 Sensitive Side Effects (in more detail) Prevident 5000 Sensitive Use in Pregnancy & Breastfeeding 0 Reviews for Prevident 5000 Sensitive - Add your own review/rating Prevident 5000 Sensitive Concise Consumer Information (Cerner Multum) APF Gel Advanced Consumer (Micromedex) - Includes Dosage Information EtheDent Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer) Gel-Kam Rinse MedFacts Consumer Leaflet (Wolters Kluwer) Phos-Flur Cream MedFacts Consumer Leaflet (Wolters Kluwer) PreviDent 5000 Sensitive MedFacts Consumer Leaflet (Wolters Kluwer) Compare Prevident 5000 Sensitive with other medications Prevention of Dental Caries

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Insuman Rapid (100 IU / ml) (sanofi-aventis)

1. Name Of The Medicinal Product

Insuman® Rapid 100 IU/ml solution for injection in a cartridge

Insuman® Rapid 100 IU/ml OptiSet® solution for injection

2. Qualitative And Quantitative Composition

Insuman Rapid is a neutral insulin solution (regular insulin).

Each ml of Insuman Rapid contains 100 IU of the active substance insulin human.

Each cartridge contains 3 ml, equivalent to 300 IU insulin.

Insuman Rapid OptiSet is a pre-filled disposable pen. Each pen contains 3 ml, equivalent to 300 IU insulin.

One IU (International Unit) corresponds to 0.035 mg of anhydrous human insulin.

The human insulin in Insuman Rapid is produced by recombinant DNA technology using K 12 strains of Escherichia coli.

For excipients, see section 6.1.

3. Pharmaceutical Form

Solution for injection in a cartridge or pre-filled pen.

4. Clinical Particulars 4.1 Therapeutic Indications

Diabetes mellitus where treatment with insulin is required.

Insuman Rapid cartridges are also suitable for the treatment of hyperglycaemic coma and ketoacidosis, as well as for achieving pre-, intra- and post-operative stabilisation in patients with diabetes mellitus

4.2 Posology And Method Of Administration

The desired blood glucose levels, the insulin preparations to be used and the insulin dosage (doses and timings) must be determined individually and adjusted to suit the patient's diet, physical activity and life-style.

Daily doses and timing of administration

There are no fixed rules for insulin dosage. However, the average insulin requirement is often 0.5 to 1.0 IU per kg body weight per day. The basal metabolic requirement is 40% to 60% of the total daily requirement. Insuman Rapid is injected subcutaneously 15 to 20 minutes before a meal.

Insuman Rapid OptiSet delivers insulin in increments of 2 IU up to a maximum single dose of 40 IU.

Insuman Rapid cartridges: In the treatment of severe hyperglycaemia or ketoacidosis in particular, insulin administration is part of a complex therapeutic regimen which includes measures to protect patients from possible severe complications of a relatively rapid lowering of blood glucose. This regimen requires close monitoring (metabolic status, acid-base and electrolyte status, vital parameters etc.) in an intensive care unit or similar setting.

Transfer to Insuman Rapid

Dosage adjustment may be necessary when transferring patients from one insulin preparation to another. This applies, for example, when transferring from:

- an animal insulin (especially a bovine insulin) to human insulin,

- one human insulin preparation to another,

- a regimen with only regular insulin to one with a longer-acting insulin.

The need to adjust (e.g. reduce) the dose may become evident immediately after transfer. Alternatively, it may emerge gradually over a period of several weeks.

Following transfer from an animal insulin to human insulin, dosage reduction may be required in particular in patients who

- were previously already controlled on rather low blood glucose levels,

- have a tendency to hypoglycaemia,

- previously required high insulin doses due to the presence of insulin antibodies.

Close metabolic monitoring is recommended during the transition and in the initial weeks thereafter. In patients who require high insulin doses because of the presence of insulin antibodies, transfer under medical supervision in a hospital or similar setting must be considered.

Secondary dose adjustment

Improved metabolic control may result in increased insulin sensitivity, leading to a reduced insulin requirement. Dose adjustment may also be required, for example, if

- the patient's weight changes,

- the patient's life-style changes,

- other circumstances arise that may promote an increased susceptibility to hypo- or hyperglycaemia (see section 4.4).

Use in specific patient groups

In patients with hepatic or renal impairment as well as in the elderly, insulin requirements may be diminished (see section 4.4).

Administration

Cartridges: Insuman Rapid in cartridges has been developed for use in the OptiPen® series. For further details on handling, see section 6.6.

OptiSet: Before using the OptiSet, the Instructions for Use included in the package leaflet must be read carefully (see 6.6).

Insuman Rapid is administered subcutaneously.

Insulin absorption and hence the blood glucose lowering effect of a dose may vary from one injection area to another (e.g. the abdominal wall compared with the thigh). Injection sites within an injection area must be rotated from one injection to the next.

Insuman Rapid cartridges may also be administered intravenously. Intravenous insulin therapy must generally take place in an intensive care unit or under comparable monitoring and treatment conditions (see "Daily doses and timing of administration").

Mixing of insulins

Insuman Rapid cartridges may be mixed with all Sanofi-Aventis human insulins, but NOT with those designed specifically for use in insulin pumps. Insuman Rapid must also NOT be mixed with insulins of animal origin or with insulin analogues.

Insuman Rapid OptiSet must not be mixed with any other insulin or with insulin analogues.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients (see section 6.1).

Insuman Rapid cartridges must not be used in external or implanted insulin pumps or in peristaltic pumps with silicone tubing.

4.4 Special Warnings And Precautions For Use

Patients hypersensitive to Insuman Rapid for whom no better tolerated preparation is available must only continue treatment under close medical supervision and – where necessary – in conjunction with anti-allergic treatment.

In patients with an allergy to animal insulin intradermal skin testing is recommended prior to a transfer to Insuman Rapid, since they may experience immunological cross-reactions.

In patients with renal impairment, insulin requirements may be diminished due to reduced insulin metabolism. In the elderly, progressive deterioration of renal function may lead to a steady decrease in insulin requirements.

In patients with severe hepatic impairment, insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism.

In case of insufficient glucose control or a tendency to hyper- or hypoglycaemic episodes, the patient's adherence to the prescribed treatment regimen, injection sites and proper injection technique and all other relevant factors must be reviewed before dose adjustment is considered.

Hypoglycaemia

Hypoglycaemia may occur if the insulin dose is too high in relation to the insulin requirement.

Particular caution should be exercised, and intensified blood glucose monitoring is advisable in patients in whom hypoglycaemic episodes might be of particular clinical relevance, such as in patients with significant stenoses of the coronary arteries or of the blood vessels supplying the brain (risk of cardiac or cerebral complications of hypoglycaemia) as well as in patients with proliferative retinopathy, particularly if not treated with photocoagulation (risk of transient amaurosis following hypoglycaemia).

Patients should be aware of circumstances where warning symptoms of hypoglycaemia are diminished. The warning symptoms of hypoglycaemia may be changed, be less pronounced or be absent in certain risk groups. These include patients:

- in whom glycaemic control is markedly improved,

- in whom hypoglycaemia develops gradually,

- who are elderly,

- in whom an autonomic neuropathy is present,

- with a long history of diabetes,

- suffering from a psychiatric illness,

- receiving concurrent treatment with certain other medicinal products (see section 4.5).

Such situations may result in severe hypoglycaemia (and possibly loss of consciousness) prior to the patient's awareness of hypoglycaemia.

If normal or decreased values for glycated haemoglobin are noted, the possibility of recurrent, unrecognised (especially nocturnal) episodes of hypoglycaemia must be considered.

Adherence of the patient to the dosage and dietary regimen, correct insulin administration and awareness of hypoglycaemia symptoms are essential to reduce the risk of hypoglycaemia. Factors increasing the susceptibility to hypoglycaemia require particularly close monitoring and may necessitate dose adjustment. These include:

- change in the injection area,

- improved insulin sensitivity (by, e.g., removal of stress factors),

- unaccustomed, increased or prolonged physical activity,

- intercurrent illness (e.g. vomiting, diarrhoea),

- inadequate food intake,

- missed meals,

- alcohol consumption,

- certain uncompensated endocrine disorders (e.g. in hypothyroidism and in anterior pituitary or adrenocortical insufficiency),

- concomitant treatment with certain other medicinal products.

Intercurrent illness

Intercurrent illness requires intensified metabolic monitoring. In many cases, urine tests for ketones are indicated, and often it is necessary to adjust the insulin dose. The insulin requirement is often increased. Patients with type 1 diabetes must continue to consume at least a small amount of carbohydrates on a regular basis, even if they are able to eat only little or no food, or are vomiting etc. and they must never omit insulin entirely.

Handling of the OptiSet pen

Before using OptiSet, the Instructions for Use included in the Package Leaflet must be read carefully. OptiSet has to be used as recommended in these Instructions for Use (see 6.6)

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

A number of substances affect glucose metabolism and may require dose adjustment of human insulin.

Substances that may enhance the blood-glucose-lowering effect and increase susceptibility to hypoglycaemia include oral antidiabetic agents, ACE inhibitors, disopyramide, fibrates, fluoxetine, MAO inhibitors, pentoxifylline, propoxyphene, salicylates and sulphonamide antibiotics.

Substances that may reduce the blood-glucose-lowering effect include corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, oestrogens and progestogens, phenothiazine derivatives, somatropin, sympathomimetic agents (e.g. epinephrine [adrenaline], salbutamol, terbutaline) and thyroid hormones.

Beta-blockers, clonidine, lithium salts or alcohol may either potentiate or weaken the blood-glucose-lowering effect of insulin. Pentamidine may cause hypoglycaemia which may sometimes be followed by hyperglycaemia.

In addition, under the influence of sympatholytic medicinal products such as beta-blockers, clonidine, guanethidine and reserpine, the signs of adrenergic counter-regulation may be reduced or absent.

4.6 Pregnancy And Lactation

There is no experience with the use of Insuman Rapid in pregnant women. Insulin does not cross the placental barrier.

It is essential for patients with pre-existing or gestational diabetes to maintain good metabolic control throughout pregnancy. Insulin requirements may decrease during the first trimester and generally increase during the second and third trimesters. Immediately after delivery, insulin requirements decline rapidly (increased risk of hypoglycaemia). Careful monitoring of glucose control is essential.

There are no restrictions on the use of Insuman Rapid in breast-feeding women. Lactating women may require adjustments in insulin dose and diet.

4.7 Effects On Ability To Drive And Use Machines

The patient's ability to concentrate and react may be impaired as a result of hypoglycaemia or hyperglycaemia or, for example, as a result of visual impairment. This may constitute a risk in situations where these abilities are of special importance (e.g. driving a car or operating machinery).

Patients should be advised to take precautions to avoid hypoglycaemia whilst driving. This is particularly important in those who have reduced or absent awareness of the warning symptoms of hypoglycaemia or have frequent episodes of hypoglycaemia. It should be considered whether it is advisable to drive or operate machinery in these circumstances.

4.8 Undesirable Effects

Hypoglycaemia

Hypoglycaemia, in general the most frequent undesirable effect of insulin therapy, may occur if the insulin dose is too high in relation to the insulin requirement. Severe hypoglycaemic attacks, especially if recurrent, may lead to neurological damage. Prolonged or severe hypoglycaemic episodes may be life-threatening.

In many patients, the signs and symptoms of neuroglycopenia are preceded by signs of adrenergic counter-regulation. Generally, the greater and more rapid the decline in blood glucose, the more marked is the phenomenon of counter-regulation and its symptoms.

Eyes

A marked change in glycaemic control may cause temporary visual impairment, due to temporary alteration in the turgidity and refractive index of the lens.

Long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy. However, intensification of insulin therapy with abrupt improvement in glycaemic control may be associated with temporary worsening of diabetic retinopathy. In patients with proliferative retinopathy, particularly if not treated with photocoagulation, severe hypoglycaemic episodes may result in transient amaurosis.

Lipodystrophy

As with any insulin therapy, lipodystrophy may occur at the injection site and delay local insulin absorption. Continuous rotation of the injection site within the given injection area may help to reduce or prevent these reactions.

Injection site and allergic reactions

In rare cases mild reactions at the injection site may occur. Such reactions include redness, pain, itching, hives, swelling, or inflammation. Most minor reactions to insulins at the injection site usually resolve in a few days to a few weeks.

Immediate-type allergic reactions to insulin are very rare. Such reactions to insulin or the excipients may, for example, be associated with generalised skin reactions, angio-oedema, bronchospasm, hypotension and shock, and may be life-threatening.

Other reactions

Insulin administration may cause insulin antibodies to form. In rare cases, the presence of such insulin antibodies may necessitate adjustment of the insulin dose in order to correct a tendency to hyper- or hypoglycaemia.

Insulin may cause sodium retention and oedema, particularly if previously poor metabolic control is improved by intensified insulin therapy.

4.9 Overdose

Symptoms

Insulin overdose may lead to severe and sometimes long-term and life-threatening hypoglycaemia.

Management

Mild episodes of hypoglycaemia can usually be treated with oral carbohydrates. Adjustments in dosage of the medicinal product, meal patterns, or physical activity may be needed.

More severe episodes with coma, seizure, or neurologic impairment may be treated with intramuscular/subcutaneous glucagon or concentrated intravenous glucose. Sustained carbohydrate intake and observation may be necessary because hypoglycaemia may recur after apparent clinical recovery.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmaco-therapeutic group: Antidiabetic agent. Insulins and analogues, fast-acting.

ATC Code: A10AB01,

Mode of action

Insulin:

• lowers blood glucose and promotes anabolic effects as well as decreasing catabolic effects.

• increases the transport of glucose into cells as well as the formation of glycogen in the muscles and the liver, and improves pyruvate utilisation. It inhibits glycogenolysis and gluconeogenesis.

• increases lipogenesis in the liver and adipose tissue and inhibits lipolysis.

• promotes the uptake of amino acids into cells and promotes protein synthesis.

• enhances the uptake of potassium into cells.

Pharmacodynamic characteristics

Insuman Rapid is an insulin with rapid onset and short duration of action. Following subcutaneous injection, onset of action is within 30 minutes, the phase of maximum action is between 1 and 4 hours after injection and the duration of action is 7 to 9 hours.

5.2 Pharmacokinetic Properties

In healthy subjects, the serum half-life of insulin is approximately 4 to 6 minutes. It is longer in patients with severe renal insufficiency. However, it must be noted that the pharmacokinetics of insulin do not reflect its metabolic action.

5.3 Preclinical Safety Data

The acute toxicity was studied following subcutaneous administration in rats. No evidence of toxic effects was found. Local tolerability studies following subcutaneous and intramuscular administration in rabbits gave no remarkable findings. Studies of pharmacodynamic effects following subcutaneous administration in rabbits and dogs revealed the expected hypoglycaemic reactions.

6. Pharmaceutical Particulars 6.1 List Of Excipients

M-cresol, sodium dihydrogen phosphate dihydrate, glycerol, sodium hydroxide, hydrochloric acid, water for injections.

6.2 Incompatibilities

As with all insulin preparations, Insuman Rapid must not be mixed with solutions containing reducing agents such as thioles and sulfites. It must also be remembered that neutral regular insulin precipitates out at a pH of approximately 4.5 to 6.5.

Concerning mixing and incompatibility with other insulins see section 4.2. Care must be taken to ensure that no alcohol or other disinfectants enter the insulin solution.

6.3 Shelf Life

2 years.

Cartridges: Once in use, the cartridges may be kept for up to four weeks. This applies irrespective of whether the cartridges are immediately put into the pen or are first carried as a spare for a while.

OptiSet: Once in use the pens may be kept for up to four weeks. This applies irrespective of whether the pens are immediately used or are first carried as a spare for a while.

6.4 Special Precautions For Storage

Store at 2°C to 8°C. Keep the container in the outer carton. Do not freeze. Ensure that the container is not directly touching the freezer compartment or freezer packs.

Cartridges: Once in use, do not store above 25°C, and protect from direct heat and light. When in use (in the pen) , do not store in a refrigerator.

OptiSet pens: Before first use, Insuman Rapid OptiSet must be kept at room temperature for 1 to 2 hours. Once in use, do not store above 25°C, and protect from direct heat and light. When in use, do not store in a refrigerator.

6.5 Nature And Contents Of Container

Cartridges

3 ml, type 1 colourless glass cartridge with bromobutyl rubber (type 1) plunger and flanged aluminium cap with bromobutyl rubber (type 1) stopper.

Each cartridge contains 3 ml solution (300 IU insulin human). Pack of 5 cartridges are available.

OptiSet

Disposable pen filled with a 3 ml, type 1 colourless glass cartridge with bromobutyl rubber (type 1) plunger and flanged aluminium cap with bromobutyl rubber (type 1) stopper.

Each cartridge contains 3 ml solution (300 IU insulin human). The cartridges are sealed in a disposable pen injector. Needles are not included in the pack. Pack of 5 pens are available.

6.6 Special Precautions For Disposal And Other Handling

Insulin pen

The cartridges are to be used in conjunction with an insulin pen such as OptiPen and other pens suitable for Insuman cartridges and as recommended in the information provided by the device manufacturer

The manufacturer's instructions for using the pen must be followed carefully for loading the partridge, attaching the needle and administering the insulin injection.

If the insulin pen is damaged or not working properly (due to mechanical defects) is has to be discarded and a new insulin pen has to be used.

If the pen malfunctions (see instructions of using the pen), the solution may be drawn from the cartridge into a syringe (suitable for an insulin with 100 IU/ml) and injected.

Cartridges

Before insertion into the pen, Insuman Rapid must be stored at room temperature for 1 to 2 hours. Inspect the cartridge before use. Insuman Rapid must only be used if the solution is clear, colourless, with no solid particles visible, and if it is of a water-like consistency.

Air bubbles must be removed from the cartridge before injection (see instructions for using the pen).

Insuman Rapid cartridges are not designed to allow any other insulin to be mixed in the cartridge.

OptiSet

Insuman Rapid must only be used if the solution is clear, colourless, with no solid particles visible, and if it is of a water-like consistency.

Empty pens must never be reused and must be properly discarded.

To prevent the possible transmission of disease, each pen must be used by one patient only.

Handling of the pen

The Instructions for Use included in the Package Leaflet must be read carefully before using OptiSet.

 

Schematic diagram of the pen

Important information for use of OptiSet:

• Before each use, a new needle must be attached and a safety test must be performed.

• The dosage selector must never be turned after the injection button has been pulled out.

• If a problem occurs with OptiSet, the section “Troubleshooting” in the Instructions for Use should be referred to.

• If OptiSet is damaged, or not working properly (due to mechanical defects) it has to be discarded and a new OptiSet has to be used.

 General Notes

- The injection button allows checking the actual loaded dose. The button should be pulled out. While holding it out, the last thick bar visible (only the top part can be seen) shows the amount of insulin loaded. If it is difficult to see, the pen may be held at an angle.

- The insulin pen must not be dropped or subjected to impact; otherwise, the insulin cartridge in the transparent insulin reservoir may break and the pen will not work. If this happens, a new pen must be used.

Step 1. Check the Insulin

After removing the pen cap, the label on the insulin reservoir should be checked to make sure it contains the correct insulin. The appearance of insulin should also be checked: the insulin solution must be clear, colourless, with no solid particles visible, and must have a water-like consistency.

Step 2. Attaching the needle

Only needles that have been approved for use with OptiSet should be used.

The needle should be carefully attached straight onto the pen.

Step 3. Safety test

Prior to each injection a safety test has to be performed.

For a new and unused OptiSet, the dose arrow should point to the number 8, as preset by the manufacturer.

Otherwise, the dosage selector should be turned until the dose arrow points to 2.

Then the injection button should be pulled out as far as it will go.

The outer and inner needle caps should be removed.

While holding the pen with the needle pointing upwards, the insulin reservoir should be tapped gently with the finger so that any air bubbles rise up towards the needle

Then the injection button should be pressed in completely.

If insulin has been expelled through the needle tip, then the pen and the needle are working properly.

If no insulin appears at the needle tip, step 3 should be repeated until insulin appears at the needle tip.

Step 4. Setting and loading the insulin dose

The dose can be set in steps of 2 units, from a minimum of 2 units to a maximum of 40 units. If a dose greater than 40 units is required, it should be given as two or more injections.

The dosage selector should be turned in either direction until the dose arrow points to the required dose.

The injection button should be pulled out as far as it will go in order to load the pen.

Step 5. Injecting the insulin dose

The patient should be informed on the injection technique by his health care professional.

The needle should be inserted into the skin.

The injection button should be pressed in completely. Then the injection button should be held down 10 seconds before withdrawing the needle. This ensures that the full dose of insulin has been injected.

Step 6. Removing the needle

The needle should be removed after each injection and discarded. This will prevent contamination as well as leakage, re-entry of air and potential needle blocks. Needles must not be reused.

The pen cap should be replaced on the pen.

Checking the reservoir for remaining insulin

The residual insulin scale on the transparent insulin reservoir shows approximately how much insulin remains in the OptiSet. This scale must not be used to set the insulin dose.

The actual loaded dose should be checked as per “General notes”. In case, the patient is not sure whether enough insulin remains in the reservoir, the OptiSet should be discarded.

Example:If the dose arrow has been set to 30 units and injection button can only be pulled out to as far as 12 units, then only 12 units insulin can be injected with this pen. In this example, either the other 18 units will have to be injected using a new pen, or the entire 30 units dose will have to be injected using a new pen.

7. Marketing Authorisation Holder

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main

Germany

8. Marketing Authorisation Number(S)

5 cartridges of 3 ml: EU/1/97/030/030

5 OptiSet pens of 3 ml: EU/1/97/030/067

9. Date Of First Authorisation/Renewal Of The Authorisation

Cartridge: 11 November 1998

OptiSet: 20 March 2000

10. Date Of Revision Of The Text

June 2006

11. Legal Category

POM

Read More:

Insuman Rapid (100 IU / ml) (sanofi-aventis)

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